Note: The job is a remote job and is open to candidates in USA. Jacobs is hiring a Commissioning, Qualification, and Validation (CQV) Project Manager to manage CQV projects for clients that manufacture GMP products. The role leads project planning and execution, ensures deliverables meet schedule, cost, scope, quality, and safety requirements, and develops client relationships and new project opportunities.
Responsibilities
- Developing CQV planning documents to manage CQV projects
- Leading the team in generating and executing CQV protocols using Good Documentation Practices (GDPs)
- Leading the team in investigating and resolving protocols exceptions or discrepancies
- Leading the team developing technical reports and CQV summary reports
- Leading the team in startup of equipment in a safe and effective manner
- Performing risk assessments and impact assessments
- Establishing appropriate procedures regarding handover of systems from construction to C&Q team as well as handover of systems from C&Q team to client
- Establishing appropriate metrics for measuring key project criteria and ensuring that project deliverables satisfy project requirements
- Developing client relationships and acting as Jacobs point of contact on project/client sites
- Seeking new project opportunities for Jacobs
Skills
- Bachelor's degree in Mechanical, Chemical, Electrical Engineering or other; or equivalent years of experience in lieu of degree
- At least 10 years of CQV experience in the Life Sciences industry
- Strong working knowledge of commissioning, qualification, and validation deliverables, team building and client relationship building
- Leadership experience, as well as experience tracking progress according to schedules and cost estimates and experience with training and mentoring junior staff members
- Proposal development experience
- Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
- Knowledge of industry guidance
- ISPE Baseline Guide 5 Commissioning and Qualification
- ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
- ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
- ISPE Guideline Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
- ISPE Good Practice Guide Applied Risk Management for Commissioning and Qualification, 2011
- Six Sigma Certification
Benefits
- Employees have access to medical, dental, vision, and basic life insurance
- A 401(k) plan
- The ability to purchase company stock at a discount
- Eligible employees may also enroll in a deferred compensation plan or the Executive Deferral Plan
- Unlimited U.S. Personalized Paid Time Off (PPTO) for full-time salaried/exempt employees
- Seven paid holidays
- Caregiver leave
- Certain roles may be eligible for additional rewards, including merit increases, performance discretionary bonus, and stock
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