IPS – Integrated Project Services, Inc.

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Job Locations US-CA-Irvine
IPS is hiring! We are looking for a talented Lead Process Engineer with Cell & Gene Therapy experience to join our industry leading Strategy & Technology team at our Irvine, California office. This position has an immediate start.   In this role, you will provide leadership in the bioprocesses associated with the latest Lentivirus and AAV based gene and cell therapies as well as ensuring that the service level is maintained and projects delivered are technically driven, accurate and of high quality. This specialist provides mentorship to our team of chemical engineers to expand the technical bioprocess knowledge of the entire IPS organization in these new therapies; this includes understanding equipment technology, process flows, material balances and deliverables consistent with our industry.   The Lead Process Engineer is responsible for designing and implementing manufacturing processes and supporting utilities on a scale that can range from developmental pilot plant to full commercial production.  Ideally, the candidate has process design and operations experience in pharmaceutical facilities, which could include Biologic, Vaccine, API (organic synthesis), oral (OSD) and parenteral (Aseptic) drug products.   KEY ACTIVITIES AND RESPONSIBILITIES - Produce conceptual design deliverables such as Process Flow Diagrams and Material and Energy Balances. - Estimate utility requirements for new manufacturing processes, design utilities generation and distribution systems. - Generate Process P&IDs (preferably on AutoCAD) that include controls strategy and CIP/SIP functions, if appropriate.  Also, generate P&IDs for critical utility systems, such as WFI, USP Purified water and Clean Steam. - Perform engineering studies for expanding, improving or automating existing facilities with limited supervision. - Produce specifications and performance data sheets for process equipment and instrumentation.  - Make use of and participate in development of company design and production tools, including process simulation and smart P&IDs. - Assume ownership of the process-related aspects of a portion of a large project or an entire small project, and provide technical support to the design team. - Establish and maintain excellent working relationships with clients and members of the IPS design team. - Special projects as assigned.
Department
Design - Process Engineering
Job Locations US-CA-Irvine | US-CA-San Francisco Bay Area
IPS is hiring! We are actively seeking an experienced Director, Process Architect, to lead our growing California and West Coast projects as we increase our presence in the pharmaceutical and biotechnology market sector. This position will be based out of our Irvine, CA or San Francisco Bay Area, CA office, and has an immediate start.    The Director, Process Architect works independently on various projects as assigned by the Director of Process Architecture.  He/she may oversee the entire design process or assist as a technical expert on a specialized design.    KEY ACTIVITIES AND RESPONSIBILITIES - Assess the requirements of a project, break a project into tasks, and work with a Project Manager to determine scope of work, budget and staffing. - Write scope of work for architectural design based on preliminary review and meetings with the client. - Knowledge of applicable building codes. Work with code officials and other design professionals when an interpretation or exception to building codes is required. - Assign and review work of project design team. Check progress of work and alert Project Manager to change of scope or additional services. - Coordinate all aspects of project document completion within company and externally with clients and other design professionals. Proficient written and oral communications skills. - Prepare or review construction budgets based on experience and scope of project. - Promote use of and participate in development of company design and production standards. - Assist in the education and development of design staff and act as resource for design questions. - Special projects as assigned.
Department
Design - Global Strategy & Technology
Job Locations US-CA-Irvine
IPS is Hiring!   We are currently searching for a Regional Procurement Manager for our West Coast Operations. This position will report directly to Director of Procurement at the headquarters location, with dotted line responsibility to the Operations Director for the region. This position will manage Procurement Buyers and Specialists within their region.   JOB DIMENSIONS Oversees and directs activities associated with client and project-related procurement and contracts administration of equipment, trade subcontracts, materials and professional services and managing the effort for assigned IPS offices. Actively manages and often engages in portfolio of all project procurement services work in the region. Develops new work for regional office with new and existing clients.   KEY ACTIVITIES AND RESPONSIBILITIES   - Seek out opportunities and leads proposal activities associated with the development of Procurement Services offerings with new or existing regional clients. - Supports intra-regional business development opportunities by other Divisions as they pertain to projects requiring Procurement Services. - Leads and closes negotiations (supported by IPS Legal) with Subcontractors, Suppliers and Professional Services providers. - Coordinates and monitors procurement and contract administration efforts on regional procurement projects. Negotiates, manages and leverages favorable agreements across business units. Provide procurement support on all projects within region. - Ensures the quality, accuracy, and completeness of department work; compliance with established IPS standards, procedures; and provides adequate training, technical and administrative guidance, and instruction to personnel with the department. - Assesses and manages procurement resources across regional projects. Supports national and intradepartmental strategic sourcing and contracting initiatives as required. - Develops strategic business plan for the procurement function in concert with overall company planning efforts involving technical/regulatory activities required to achieve long range and annual goals and objectives. - Leads or supports the development of departmental policies, standard operating procedures (SOP’s), tools, templates and work instructions governing the procurement function. Assists in the development and coordination of divisional and inter-departmental policies, procedures, and standards. - Implements quality system by making recommendations to improve system, implement department level processes as well as overall regional office implementation. - Directly manages various personnel functions, including, but not limited to, hiring, project staffing decisions, performance appraisal, salary position recommendations, and employee development. - Conducts regular meetings with procurement specialists, project managers and project leaders of all disciplines to ensure open lines of communication across all disciplines within the regional operation. - Attends and contributes to recurring global group meetings. Collaboratively works with other Procurement Managers on resource allocation, leveling and effort-sharing across the broader organization. CONTEXT AND ENVIRONMENT This position requires 25% travel to regional offices and client sites. Work environment is office-based either in regional office or at client sites (job trailers and/or client-supplied workstation). Position is required to maintain proficiency in OSHA regulations (must complete OSHA 10 training at minimum) via the IPS Learning Management System.  
Department
Construction
Job Locations US-CA-Irvine
IPS is hiring in Southern California! We are looking for a talented Senior Mechanical Engineer to join our industry leading Mechanical Engineering team at our Orange County office located in Irvine, CA. Experience in pharmaceutical or biotechnology, clean rooms and HVAC is required.   The Senior Mechanical Engineer works independently on various projects as assigned by a Project Manager or Group Leader. The Senior Mechanical Engineer may oversee the entire HVAC/Utilities design process or assist as a technical expert on a specialized design, work on several concurrent projects and is recognized as the Subject Matter Expert (SME) for Mechanical Engineering within the Pharmaceutical, Biotech, Life Sciences or Laboratory industries.      Job Duties and Responsibilities - Assesses project requirements, breaks projects into tasks and works with Project Managers to determine scope of work while overseeing budget and staffing. - Writes scopes of work for mechanical designs (HVAC/Utilities) based on preliminary review and client meetings. - Prepares engineering studies and schematic design for new HVAC/Utilities systems and analyzes the operation of existing systems. - Works with code officials and other design professionals when an interpretation or exception to building codes is required. - Assigns and reviews the work of the project design teams, checks the progress of the work and alerts Project Managers of scope changes or additional services. - Reviews contractor applications for payments and maintains a thorough understanding of the construction process. - Coordinates all aspects of project document completion within IPS, externally with clients and with other relevant design professionals.  - Prepares or reviews construction budgets based on the project scope.    - Develops and promotes the use of IPS design and production standards. This position is a safety sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research or other "non-administrative" areas.
Department
Design - Mechanical Engineering
Job Locations US-CA-Irvine
IPS is Hiring! We are looking for a talented Sr. CQV Lead / Department Manager to join our industry leading CQV/Validation Team at our growing Orange County office located in Irvine, California.   In this role, the Sr. CQV Lead / Department Lead performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. Interfaces directly with IPS clients in the delivery of projects including routine communications, leading project meetings, tracking and reporting project metrics (financial and deliverables), self-directing and directing of assigned project team, maintains positive client relationship, etc. May also manage and perform standalone commissioning services for non-FDA regulated clients.   KEY ACTIVITIES AND RESPONSIBILITIES - Assist an assigned Project Manager or is directly responsible for the successful delivery of compliance projects to IPS’ clients. Leads independent (sole individual), small, or mid-sized projects on behalf of IPS. - IPS point of contact to client for day-to-day project delivery. Runs meetings, communicates status and project issues, frequently “checks-in” with client representative(s), and facilitates general project coordination activities. - Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project managers or management of project status and issues. Develop project schedules, deliverable tracking reports, scope adjustment notices, etc. - Support, train, and provide guidance to validation specialists/engineers in the delivery of C/Q/V services for assigned projects. - Write and manage others in the preparation of C/Q/V documents following established standards and templates, including but not limited to the following: - C/Q/V Master Plans - Commissioning Forms - C/Q/V Protocols and Summary Reports - Standard Operating Procedures - Impact Assessments - Specifications (URS/FRS/DDS) - FATS/SATs - Perform and manage others during field/site activities including, but not limited to, the following: - Attend and witness FATs and SATs as a representative of IPS clients. - Execution of commissioning forms and witnessing of vendor start-up and testing. - Execution of C/Q/V protocols. - Walkdown and verification of system drawings (P&IDs, as-builts, etc.) - Perform and manage staff in compiling data packages and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc. - Assist in deviation investigation and resolution of problems and issues encountered during field execution activities. - Coordinate with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required. - Audit project deliverables to assure compliance with established standards. Review work of assigned project team. - Assist in proposal development including scope definition, attend bid meetings, development of hours and cost budgets, proposal presentations, etc. - Act as an IPS representative for developing new opportunities and continue to support repeat business. - Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries. - Must be self sufficient and effectively work with limited to no supervision. - Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services. - Other duties as assigned. #IAmIPS #IPSCaliforniaJobs #greatplacetowork #greatcolleagues #industryleaders
Department
CQV - Validation
Job Locations US-CA-Irvine
Under the direct supervision of the Group Lead and Director of Architecture, The Senior Architect works independently on various projects as assigned by Director of Architecture.  He/she may oversee the entire design process or assist as a technical expert on a specialized design. The Senior Architect may work on several concurrent projects. When leading a project team environment, the Senior Architect will supervise his/her team members which may consist of Architects I, II, Architectural Designer I, II, or Senior Architectural Designer.   KEY ACTIVITIES AND RESPONSIBILITIES - Assess the requirements of a project, break a project into tasks, and work with a Project Manager to determine scope of work, budget and staffing. - Corrects and updates design documents. Develops solutions to design problems. Reviews drawings and documents to assure compliance with company, regulatory agencies, and production standards. - Provides oversight for Architectural construction administration activities such as preparing bulletins, construction sketches, submittal review, and RFI responses as well as performing on-site observations and field support when called upon. - Ability to develop Conceptual and Preliminary “BOD” write-ups based on client meetings - Knowledge of applicable building codes. Work with code officials and other design professionals when an interpretation or exception to building codes is required. - Assign and review work of project design team. Check progress of work and alert Project Manager to change of scope or additional services. - Capable of recognizing design support abilities of team and empowering those to have opportunities to elevate their design capabilities through my challenging assignments. - Ensures project specifications are delivered with company quality standards and are delivered on time as required by the client. - Has comprehensive knowledge of building design including both building and GMP cleanroom compliance experience. - Demonstrates the ability and interest to develop conceptual ideas to present to clients during proposal presentations. - Research equipment selection from catalogs as needed for the project. - Ensure acceptable levels of quality and checks for coordination of work to assure documents reflect design intent and necessary coordination - Coordinates architectural design work with related engineering disciplines. Attend job and construction meetings and participate in the coordination of the work - Assists the design team with design solutions by having the ability to interpret drawing mark-up drawings and execute changes on the project based on such mark-ups - Review contractor application for payments. Has a thorough understanding of construction process. - Coordinate all aspects of project document completion within company and externally with clients and other design professionals. Excellent written and oral communications skills. - Prepare workplans or review construction budgets based on experience and scope of project. - Promote use of and participate in development of company design and production standards. - Assist in the education and development of design staff and act as resource for design questions. - Special projects as assigned.
Department
Design - Architecture
Job Locations US-CA-Irvine
Responsible for oversight of multiple EPCMV Project Teams day to day execution within Regional Operations of <$50MM project delivery organization. Focuses on the support of EPCMV and CM services sales, overseeing the detailed execution of projects by his teams from initiation to close out, development of staff and operational performance of division.   KEY ACTIVITIES AND RESPONSIBILITIES - Supporting the Regional Operations Director and / or Sr. Project Director, leads Project Delivery Team(s) activities including field services, safety, preconstruction services, procurement, estimating, cost and schedule and design assist subcontractor interface and integration into the overall EPCMV project delivery with the Design and Compliance Divisions. - Supports the Regional Operations Director in the establishment of goals and development of the execution plan for the Project Delivery team(s). - Periodically monitors performance versus project goals and implements corrective actions. - Supports the Regional Business Unit Leader and / or Regional Operations Director in the business development functions for the Project Delivery group. - Supports the Preconstruction, Project Services, Procurement, Quality and Safety groups with work assignments and resources. - Protects our corporation through application of prudent risk management techniques. - Provides day-to-day direction of all Project Delivery group operations, including preconstruction, estimating, procurement, project management, construction site management, and construction site safety. - Oversees the development of Project Delivery group contracts and subcontracts, aggressively protecting corporate positions. - Oversees project execution planning across all Project Delivery group projects. - Oversees project estimating and budgeting across all Project Delivery group projects. - Directs the Change Management process. Provides Work-In-Place analysis with the Project Controls group. - Coordinates and assist the Director of Ops in the day-to-day responsibility for the hiring, training, and development of Project Delivery group staff. - Works with Sr. Project Managers and Project Managers to resolve project cost, schedule, and quality non-conformances. - Surveys and monitors construction sites as required to meet other responsibilities. - Meets with clients as required for additional responsibilities. Serves as secondary point of contact to Sr. Project Manager and/or Project Manager for clients. - Leads the execution of Project Delivery group systems, procedures, and policies. - Reviews project performance with Project Delivery group staff on a periodic basis. - Coordinates and assist the Director of Ops in the group activities to ensure achievement of budgeted revenue and profits. - At the request of the Regional Operations Director as needed, participates on IPS' Project Management Team to develop project execution strategy. - Coordinates with Regional Operations Director and Regional Business Unit Leaders and other IPS Divisions Leadership to optimize achievement of overall corporate objectives. - Evaluates Project(s) resource requirements and manages Project(s) staff levels to support those requirements. - Trains project assignees on good project management techniques and develops skills of all assigned personnel. - Assures that utilization targets are met for the Project Delivery group in the Region. - Supports project/client development process with presentations and related marketing activities. - Coordinates with Regional Business Unit Leaders and Operations Directors of other IPS divisions to pursue business opportunities. - Prepares and supports Regional Operations Director in preparation of Project Delivery proposals. - Other duties as assigned.
Department
Construction
Job Locations US-CA-Irvine
Performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone commissioning services for non-FDA regulated clients.   KEY ACTIVITIES AND RESPONSIBILITIES - Write C/Q/V documents following established standards and templates, including but not limited to the following: - Commissioning Forms - C/Q/V Protocols and Summary Reports - Standard Operating Procedures - Impact Assessments - Specifications (URS/FRS/DDS) - FATS/SATs - Perform field/site activities including, but not limited to, the following: - Attend and witness FATs and SATs as a representative of IPS clients. - Execution of commissioning forms and witnessing of vendor start-up and testing. - Execution of C/Q/V protocols. - Walkdown and verification of system drawings (P&IDs, as-builts, etc.) - Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc. - Assist in deviation investigation and resolution of problems and issues encountered during field execution activities. - Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required. - Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries. - Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services - Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested. - Other duties as assigned. DEMONSTRATED COMPETENCIES - Proficiency with Microsoft Office applications (Word, Excel, Project, Powerpoint, etc). - Personal skills and traits include: - Sense of urgency - Team player - Able to multi-task - Effective time management - Able to effectively prioritize - Good interpersonal skills - Attention to detail - Excellent customer service skills - Leads by example. Deems the respect of upper management, peers and subordinates. Empowers staff to succeed. - Supports and deploys technical training programs that assure competency and advancement levels to support corporate goals. - Promotes a friendly and efficient work environment, which rewards achievement and recognizes teamwork and champion’s technical advancement, which supports our corporate goals. Maintain professional conduct and deliver services in a professional and acceptable fashion. - Works in conjunction with department management in recruiting new staff members and promoting IPS to potential hires (focused on cleaning and process validation).   Core Value Candidate Qualifications - Must exhibit an entrepreneurial spirit by consistently seeking new opportunities to add value to the organization. Must strive for excellence in all aspects of job performance.  Must approach their work enthusiastically with a contagious energy and drive that shows everyone they love what they do. - Must display creativity and innovation by continually working to improve solutions, tools, methods and service delivery system. - Must conduct oneself with an uncompromising commitment to the welfare of our clients and each other. Must act in an ethical, professional and respectful manner at all times. - Must exhibit the ability to build and sustain long term relationships of mutual value through teamwork. - Must be driven to succeed and committed to goal attainment.  
Department
CQV - Validation
Job Locations US-CA-Irvine
This position will report to the Sr. Director, Project Management. Direct reports can be Project Managers, Assistant Project Managers & Project Engineers.   The Senior Project Manager provides leadership on assigned projects and acts to achieve financial, schedule, and client relationship objectives.  The Senior Project Manager plans and organizes all engineering functions specific to the project, coordinates client interaction between the project team and client, provides guidance on recommended manpower and technical resource loading.  The Senior Project Manager will strive to improve and increase client relationships.   Key Activities and Responsibilities   - Project Size – All. - Holds primary responsibility for achievement of scope, cost, schedule and quality objectives on assigned projects. - Ensures achievement of corporate goals for assigned projects. - Attends pre-bid meetings with clients and prepares proposals in conjunction with department heads, directors and other key individuals. - Actively assists in Design budget development. - Manages client interaction on assigned projects and promotes positive relationships. - Identifies risks to project and corporation and works with Project Executives and Director of Operations to mitigate risks. - Responsible for project scope control and development/communication of all scope adjustment notifications (SAN) to the client. - Coordinates with project discipline leads to determine scope, complexity, and planning and scheduling requirements of the projects. - Develops and maintains meeting minutes and Action Items/Needs List for each project. - Develops and Maintains Project Execution Plan. - Prepares internal monthly financial/schedule reports for the Director of Operations for each project. - Prepares monthly financial/schedule reports for the Client as requested by the client. - Enhances and facilitates project team communication and coordination. - Responsible for management of all sub-consultants on the project. - Must have the ability to run multiple simultaneous projects. - Maintains personal competency in relevant professional areas. - Develops and maintains long-term industry relationships including client relationship and account development. - Assists in identifying, and developing innovative methods for improving project management processes and techniques against current SOPs. - Strives for continuous improvement in all internal processes. - Other duties as assigned.   This position is a safety sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research or other "non-administrative" areas.
Department
Design - Project Management
Job Locations US-CA-Irvine
Under the direct supervision of the Architect I, II, or Senior Architect, the Senior Architectural Designer works with a team of Designers, Architects and Engineers to assist with the design and development of architectural projects in an effort to help meet or exceed the expectation of the customer (client). This individual may supervise a less senior designer however will primarily work on technical aspects of a project.   KEY ACTIVITIES AND RESPONSIBILITIES - Corrects and updates design documents. Develops solutions to design problems. Reviews drawings and documents to assure compliance with company design and production standards. - Assists in the development of design documentation for the following design phases; masterplanning, schematic, preliminary, and construction documentation. - Proactively alerting team members of a project design change which may affect time and costs of the project.  - Keeps Project Team aware of workload and requests additional resources and work assignments ahead of schedule - Works with equipment suppliers/vendors to obtain the necessary information needed for design completion. - Interacts with clients on a limited basis to secure scope and design intent. - Research equipment selection from catalogs under the direction of the Architect. - Ensure acceptable levels of quality and checks for coordination of work to assure documents reflect design intent and necessary coordination - Support construction administration activities such as preparing bulletins, construction sketches, submittal review, and RFI responses as well as performing on-site observations and field support when called upon. - Coordinates architectural design work with related engineering disciplines. Attend job and construction meetings and participate in the coordination of the work - Capable of recognizing design support abilities of team and empowering those to have opportunities to elevate their design capabilities through my challenging assignments. -  Assists the design team with design solutions by having the ability to interpret drawing mark-up drawings and execute changes on the project based on such mark-ups - Uses Revit to develop architectural design documentation that aligns with company BIM/CAD standards.  - Reviews drawings and documents to assure compliance with company design and production standards. - Ability to work as a team member and capable of interpreting the Project Architect's design requests. - Participate in architectural design work coordination with related engineering disciplines. - Supports and/or leads field visits and site surveys when requested by the Architect - Capable of creating renderings, generate diagrams and special projects as assigned.
Department
Design - Architecture
Job Locations US-CA-Irvine
Performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone commissioning services for non-FDA regulated clients.   KEY ACTIVITIES AND RESPONSIBILITIES - Write C/Q/V documents following established standards and templates, including but not limited to the following: - Commissioning Forms - C/Q/V Protocols and Summary Reports - Standard Operating Procedures - Impact Assessments - Specifications (URS/FRS/DDS) - FATS/SATs - Perform field/site activities including, but not limited to, the following: - Attend and witness FATs and SATs as a representative of IPS clients. - Execution of commissioning forms and witnessing of vendor start-up and testing. - Execution of C/Q/V protocols. - Walkdown and verification of system drawings (P&IDs, as-builts, etc.) - Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc. - Assist in deviation investigation and resolution of problems and issues encountered during field execution activities. - Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required. - Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries. - Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services - Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested. - Other duties as assigned.
Department
CQV - Validation
Job Locations US-CA-Irvine
The Lead Process Automation Engineer provides the IPS project team with technical leadership and automation expertise and instrumentation support for the design, engineering, construction, and qualification of Pharmaceutical and Biotech related projects.   KEY ACTIVITIES AND RESPONSIBILITIES   Provide Automation engineering support in the following:   Leadership - Develops project execution plans (budget, milestones, deliverables, and staffing plans) and manages work in accordance with those plans to deliver project on time, on budget, and of the highest quality. - Demonstrate subject matter expertise by developing department standards and improving existing work practices. - Progressive ability and aptitude to develop and mentor junior staff member Conceptual Design - Leads client in strategic evaluations to develop concepts supported by engineering studies for expanding, improving or automating existing facilities.  - Working with clients, other IPS disciplines, vendors to develop complete Automation solutions. - Consulting on the proper adoption of the ISA S95 levels to meet the client’s needs now and in the future. - Basis of Design - Coordinates with project managers to determine project scope, complexity and schedule for project development.  - Writes scope of work for process, utilities and manufacturing controls based on preliminary reviews with the client. - Reviewing and advising client on design decisions and capturing all pertinent decisions in project reports. Detailed Design - Actively collaborate with the process design and project teams to support execution of successful project studies. - Develop the design and specifications for DCS, PLC and SCADA based process control systems for IPS clients and projects. - Perform automation related job functions as assigned, including, I/O lists, Instrumentation lists and the specification of instrumentation and control element.  Construction Assistance - Support IQ/OQ development and participate in systems analysis, validation and verification. - Identify, qualify and collaborate with third party system integrators as necessary to support project and company business objectives. - Work with end users and Original Equipment Manufacturers (OEM’s) to coordinate application of automation products.
Department
Design - Process Automation
Job Locations US-CA-Irvine
Performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone commissioning services for non-FDA regulated clients.   KEY ACTIVITIES AND RESPONSIBILITIES - Write C/Q/V documents following established standards and templates, including but not limited to the following: - Commissioning Forms - C/Q/V Protocols and Summary Reports - Standard Operating Procedures - Impact Assessments - Specifications (URS/FRS/DDS) - FATS/SATs - Perform field/site activities including, but not limited to, the following: - Attend and witness FATs and SATs as a representative of IPS clients. - Execution of commissioning forms and witnessing of vendor start-up and testing. - Execution of C/Q/V protocols. - Walkdown and verification of system drawings (P&IDs, as-builts, etc.) - Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc. - Assist in deviation investigation and resolution of problems and issues encountered during field execution activities. - Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required. - Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries. - Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services - Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested. - Other duties as assigned.  
Department
CQV - Validation

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