CQV Manager

2 weeks ago


Gaithersburg, United States IT Minds LLC Full time

Sr. CQV Manager

LOA: 12 months

Gaithersburg, MD

Client is looking for a C&Q Manager to assist the GERE Americas Team with two projects currently in the Basic Design phase.

This is expected to be a full-time position (40 hours per week) through March 2026 and move to 20 hours per week thereafter until September 2026 (the end of the assignment).

Attached you will find the Job Description for the role we are looking to fill (with a strong preference to someone with a mechanical background).

This role will be based out of Gaithersburg, the ideal candidate would be local or within 50 miles of site to allow on-site presence (hybrid options will be available up until November 2024, from that point on the position will be fully on-site).

The Commissioning & Qualification (C&Q) Manager reports to the Project Manager (PM) and is a key member of the project management team. The C&Q Manager works closely with contractors and their sub-contractors during commissioning and qualification phase to ensure safe and successful project delivery by overseeing their delivery approach, management and deliverables are executed as per approved project VMP, VP and other associated project procedures.

Roles and Responsibilities:

  • Assist the Project Manager (PM) to establish appropriate C&Q stage strategy, scheduling and resources plans required for Stage 2 and Stage 3 deliverables.
  • Support the PM to manage the relationship of Customer stakeholders especially Site Quality for GMP compliance and Customer Rep team responsible for operational readiness.
  • Ensure that project VMP is established and approved for use (which may include writing as agreed with Site Quality)
  • Develop C&Q Plan in accordance with the project VMP and oversee the completion of C&Q planning assessment SIA, Risk Assessments, Vendor Assessment and others as per AZ C&Q procedures.
  • Work closely with Construction Manager to ensure seamless transition of systems from MC to start-up.
  • Oversee and management the completion of project C&Q documentation such as protocols in a timely manner.
  • Oversee execution of Safe to Start review before system energization.
  • Oversee and manage live system operations during C&Q phase if system is still under project team care and custody including management of live system status board.
  • Support implementation of the Client SHE Requirements with Project Construction SHE Manager focusing on risks during start-up, commissioning, and qualification phase. Support use of Reporting and Observation PM-Vitals.
  • Lead and manage C&Q/CSV resources (personnel, documentation, test equipment) to ensure successful execution of C&Q/CSV within project schedule and budget.
  • Ensure that appropriate training for C&Q resources are completed for their role.
  • Approval and acceptance of systems and construction Turnover Packages at Mechanical Completion.
  • Oversight and Governance that commissioning and qualification protocol results, raw data calculations, and completed test scripts have met established acceptance criteria and been reviewed to client standards, processes and procedures.
  • Review and oversight of FAT and SAT events and documentation. Approval and acceptance of equipment on SAT completion.
  • Oversee and manage system calibration and tuning during C&Q phase in a

Report C&Q progress to PM to be incorporate into monthly Project Progress Report.

  • Develops and maintains a commissioning and qualification PDR Board of system energization, commissioning, and qualification activities.
  • Lead and manage deviation closeout process during C&Q phase.

Best Regards,

Satish J | IT Minds LLC

Direct: |Email:


  • Cqv Manager

    2 weeks ago


    Gaithersburg, United States IT Minds Llc Full time

    **Sr. CQV Manager** **LOA: 12 months** **Gaithersburg, MD** Client is looking for a C&Q Manager to assist the GERE Americas Team with two projects currently in the Basic Design phase. This is expected to be a full-time position (40 hours per week) through March 2026 and move to 20 hours per week thereafter until September 2026 (the end of the...

  • CQV Manager

    2 weeks ago


    Gaithersburg, United States IT MINDS L.L.C. Full time

    Job DescriptionJob DescriptionSr. CQV ManagerLOA: 12 moGaithersburg, MDClient is looking for a C&Q Manager to assist the GERE Americas Team with two projects currently in the Basic Design phase .This is expected to be a full time position (40 hours per week) through March 2026 and move to 20 hours per week thereafter until September 2026 (the end of the...


  • Gaithersburg, United States IT MINDS L.L.C. Full time

    Job DescriptionJob DescriptionSr. CQV Manager LOA: 12 months Gaithersburg, MDRate: $65/hr on C2CClient is looking for a C&Q Manager to assist the GERE Americas Team with two projects currently in the Basic Design phase . This is expected to be a full time position (40 hours per week) through March 2026 and move to 20 hours per week thereafter until September...

  • Validation Engineer

    4 days ago


    Gaithersburg, United States Katalyst HealthCares & Life Sciences Full time

    Responsibiltiies: Develop comprehensive protocols for the qualification/requalification of new and existing QM micro and QC analytical equipment. Develop comprehensive protocols for the qualification of required clean utilities to service new QC Micro and QC analytical laboratory. Develop comprehensive protocols for the qualification of new EMS...


  • Gaithersburg, United States AstraZeneca Full time

    Are you ready to foster an attitude of excellence? Join AstraZeneca's Operations team as the Associate Director of Quality Engineering. In this role, you will be responsible for the oversight of the Quality Risk Management, CQV, CSV programs for the Cell Therapy operation of the Rockville Manufacturing Center (RMC) facility. This includes Quality Review and...