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 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
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
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
The Sustainability Engineer II will assist the greater project team to leverage opportunities in the project design phase and beyond to reduce energy, carbon, water and waste intensities. Projects are primarily in the life science, biotech and pharmaceutical manufacturing sector, and frequently contribute to larger client portfolio standards and targets around scope 1, 2 and 3 emissions and intensity reductions. This individual must be technically and analytically minded, and able to articulate ideas and concepts, using research of proven strategies and the latest technologies to guide fellow colleagues and partners towards innovative designs. The individual must understand the nature of change management and be prepared to defend ideas and earn buy in, among both colleagues and clients. Some travel nationally may be expected.     KEY ACTIVITIES AND RESPONSIBILITIES - Assist the Sustainability team and collaborate with project teams to identify opportunities for sustainable design, construction and operations strategies. - Analyze feasibility for rating systems like LEED and WELL. - Collect data and metrics for internal and corporate reporting requirements of frameworks such as CDP and GRI. - Research the latest advances in sustainable technologies for both general building design and specialized manufacturing processes. Focus areas include energy, carbon, water, waste and health & wellbeing. - Generate reports and presenting of findings. - Organize information in a collaborative, knowledge sharing fashion, collecting and developing lessons learned and case studies. - Promote the advancement of the green building industry, collaborating with local and national industry groups and participating in conferences and webinars. - Organizing research and reference material in an easily accessible manner.
Department
Design - Global Strategy & Technology
Job Locations US-CA-Irvine
The Sustainability Engineer III will leverage opportunities in the project design phase and beyond to reduce energy, carbon, water and waste intensities. Projects are primarily in the life science, biotech and pharmaceutical manufacturing sector, and frequently contribute to larger client portfolio standards and targets around scope 1, 2 and 3 emissions and intensity reductions. This individual must be technically and analytically minded, and able to articulate ideas and concepts, using research of proven strategies and the latest technologies to guide fellow colleagues and partners towards innovative designs. The individual must understand the nature of change management and be prepared to defend ideas and earn buy in, among both colleagues and clients. Some travel nationally may be expected.  This position would ideally be based out of our Blue Bell, PA or Irvine, CA office but the position is open to any candidate within close proximity to any IPS office in the US.   KEY ACTIVITIES AND RESPONSIBILITIES - Collaborate with project teams to identify opportunities for sustainable design, construction and operations strategies. - Analyze feasibility for rating systems like LEED and WELL. - Collect data and metrics for internal and corporate reporting requirements of frameworks such as CDP and GRI. - Research the latest advances in sustainable technologies for both general building design and specialized manufacturing processes. Focus areas include energy, carbon, water, waste and health & wellbeing. - Generate reports and presenting of findings. - Organize information in a collaborative, knowledge sharing fashion, collecting and developing lessons learned and case studies. - Promote the advancement of the green building industry, collaborating with local and national industry groups and participating in conferences and webinars.
Department
Design - Global Strategy & Technology
Job Locations US-CA-Irvine
The Sr. EHS Specialist assists in maintaining compliance with EHS policies and regulations for engineering services, construction projects and validation/compliance services. Visits client sites to audit and inspect project compliance. Assists in administrative compliance activities as directed.   KEY ACTIVITIES AND RESPONSIBILITIES - Assist construction project teams by supporting subcontractor qualifications, Safety Plan development, Safety plan implementation, project compliance inspections and project EHS regulatory guidance. - Research regulations and assist with construction site EHS compliance. - Visit IPS work sites to assist in EHS compliance. Perform EHS compliance audits and inspections at IPS project sites. Record and report audit reports and assist with implementation of corrective actions. - Provide on-site EHS support for projects that require continuous oversight. May involve travel to project locations for several days to several weeks. - Review and evaluate daily Job Safety Analysis developed by subcontractors. - Assist with Safety metrics recording and reporting. - Plan and attend meetings as requested and support EHS department administrative functions - Demonstrate and advocate for safety and SOP requirements. Exemplify safety values, policies and procedures that all IPS employees are expected to follow. - Other duties as assigned.
Department
Construction
Job Locations US-CA-Irvine
IPS is hiring! We are actively seeking a talented Senior Corporate Recruiter to join our Talent Acquisition Team in California. This position can be based out of our Irvine or San Francisco Bay office locations. (Flexible work options are available)   KEY ACTIVITIES AND RESPONSIBILITIES - Collaborates with Division Leaders and hiring managers to identify project needs and desired qualifications for staff. - Plans and implements recruiting programs based on qualifications and job descriptions for anticipated vacancies. - Drafts and publicizes recruitment efforts in appropriate and relevant places that may include online sources such as LinkedIn, and educational and professional journals and publications. - Manages correspondence and relationships with college placement officers, engineering professors, and professional employment services. - Attends engineering job fairs. - Reviews resumes, verifies academic records and previous work experience, and conducts interviews or identifies the appropriate staff or agency to conduct these tasks. - Schedules and arranges for promising candidates to visit the company and interview with department managers and supervisors. - Provides salary range guidance based on current, competitive compensation levels in the area. - Maintains contacts in the engineering community through active participation and membership in professional societies. - Other duties as assigned.
Department
Human Resources
Job Locations US-CA-Irvine
Work performed with minimal supervision; has considerable latitude in determining objectives and approaches to assignments. Performs complex, significant project-related tasks by providing various CAD/BIM drafting functions for Engineering, Design, and Construction staff. This position works with the staff of all disciplines to standardize design software across the organization. This is an office based position that will be responsible for establishing, monitoring and enforcing IPS design standards.   KEY ACTIVITIES AND RESPONSIBILITIES - The Sr. BIM Coordinator is responsible for researching and standardizing BIM workflows across our design, construction and Asset Management practice as well as organizing and communicating BIM technical information for a global A/E. - Must understand the practice of architecture, engineering and construction in order to support those professionals with the ability to standardize, support and present technology solutions. This includes sales/client-facing presentations and meetings. - Maintain and develop standardized processes, document best practices, and provide for BIM knowledge sharing within the BIM department and throughout IPS. - Knowledge of drafting principles and plan set assembly is required. - Coordinates and performs BIM/CAD systems maintenance: determines what items are needed for hardware maintenance; replaces parts, repairs operating system and other needs required for design software on workstations; etc. - Performs user support duties as necessary: assists with development of a standards manual; coordinates and distributes revisions to the standards; answers internal calls regarding BIM/CAD related problems and troubleshoots as needed. - Challenging current BIM practices, guiding the resulting technology transformation. - Liaison with IT and project staff to ensure functional and efficient hardware and software setups for staff, at colocation facilities, and on jobsites - Evangelizing design technology applications, promoting solutions, and analyzing application usage metrics. - Provide BIM implementation oversight on projects; develop BIM Execution Plans; and calculate technology ROI and other metrics to IPS Business/ Ops Leadership. - Collaborate with project teams to develop a specific project technology approach. - Utilize Virtual Reality technology, Drones, and any new technology that will help or be required on a project. - Use CAD/BIM software to aid in VDC tasks such as; AutoCAD, Revit, Plant 3D/P&ID, and any other required 2D and 3D software. - Provide general BIM tech support for project engineers. - Work with Project Managers and Design Mangers at the start of a project by recommending the appropriate software tools and project execution methodology. - Communicate with engineers, architects and/or clients to take delivery of and convert submitted drawings for use by all disciplines. - Provide all other Engineering & Design support tasks including but not limited to: processing shop drawing comments and computer-aided drafting & design. - Special projects as assigned.
Department
Design - CAD/BIM

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