IPS – Integrated Project Services, Inc.

  • Job Locations US-CA-Newark
    CQV - Validation
    # of Openings Remaining
    Position Type
    Regular Full-Time
    Location : Location
  • Position Responsibilities

    IPS is hiring in Nor Cal! We are looking for a CQV Engineer II (Validation) to join our industry leading commissioning, qualification and validation team at our client site in the Newark, CA area. Must have previous life science experience (pharmaceutical, biotech, nutraceutical, etc.). CGMP experience is strongly preferred. 


    In this role, you will perform CGMP compliance based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Follow 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.


    Job Duties and Responsibilities

    • Write 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 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.
    • Assists in deviation investigation and resolution for 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.
    • Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech and medical device industries.
    • Be self-sufficient and effectively work with limited supervision.
    • 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.
    • Review the work of others and completed test scripts as an IPS representative.
    • Develop client relationships and act as IPS liaison on project/client sites.
    • Maintain professional conduct and deliver services in a professional and acceptable fashion.
    • Make recommendations to IPS for possible project and procedural improvements.
    • Support and provide guidance for Level I & Tech staff and co-ops in the delivery of C/Q/V services.
    • Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies.
    • Special projects as assigned.

    Qualifications & Requirements

    • Bachelor of Science in Engineering is required.
    • Three-six (3-6) years of industry experience in pharmaceutical, biotech, medical device design, commissioning, validation or quality assurance. Experience in writing and execution of PFC, FC, IQ, OQ and PQ forms and protocols for CGMP utilities, equipment, systems and software.
    • General exposure and experience in a CGMP/validation discipline with a knowledge and understanding of pharmaceutical design/build/commission/validate processes and how they relate to regulatory requirements and CGMP regulations within the E.U. and U.S. FDA.
    • Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, Outlook).
    • Experience with cleaning, process, computer system, methods and other validation activities and processes is beneficial.
    • Experience with risk-based approach to commissioning and qualification is beneficial.
    • 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

    Company Overview

    About Us


    IPS-Integrated Project Services is a global leader in developing innovative and cost effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends and regulatory environment to successfully deliver capital projects and improve operations. For over thirty years, we have applied unique LEAN methodologies throughout the project life cycle, continually finding ways to do things better and more efficiently, delivering higher quality and controlling costs. Headquartered in Blue Bell, PA, IPS is a multi-national company with over 1,300 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Ireland, Singapore, Switzerland, UK and four locations in India. Visit our website at www.ipsdb.com.




    Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.


    IPS is an equal opportunity, affirmative action employer of protected veterans (M/F/D/V). IPS will consider qualified applicants with criminal histories.


    Attention Search Firms / Third Party Recruiters:  IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via-email, the Internet or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.


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