CQV Project Manager : Life Sciences - Cary, NC​/Houston, TX​/Richmond, VA Req

CQV Project Manager :
Life Sciences - Cary, NC/Houston, TX/Richmond, VA Req 31778

Base pay range: $/yr – $/yr

As a Commissioning, Qualification, and Validation (CQV) Project Manager at Jacobs, you will join a collaborative team providing CQV project management to clients that manufacture GMP products on a consistent basis. This client‑facing position emphasizes ensuring CQV project deliverables meet schedule, cost, scope, quality, and safety.

Responsibilities

• Develop CQV planning documents and lead the execution of CQV protocols using Good Documentation Practices (GDPs).
• Investigate and resolve protocol exceptions or discrepancies and generate technical reports and CQV summary reports.
• Lead startup of equipment in a safe and effective manner; perform risk assessments and impact assessments.
• Establish procedures for handover of systems from construction to C&Q team and from C&Q team to client.
• Measure key project criteria with appropriate metrics and ensure project deliverables satisfy requirements.
• Develop client relationships and act as Jacobs point of contact on project/client sites; seek new project opportunities for Jacobs.

Qualifications

• Bachelor’s degree in Mechanical, Chemical, or Electrical Engineering or equivalent years of experience.
• At least 10 years of CQV experience in the Life Sciences industry.
• Strong knowledge of commissioning, qualification, and validation deliverables; team building and client relationship building.
• Leadership experience, tracking progress according to schedules and cost estimates, and training/mentoring junior staff members.
• Flexibility and willingness to travel to various client locations.

Preferred

• Proposal development experience.
• Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations.
• ISPE Baseline Guide 5 Commissioning and Qualification; ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems;
  Six Sigma certification.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.