You’ll be accountable for 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, and leading the team in startup of equipment in a safe and effective manner; as well as performing risk assessments and impact assessments. You’ll also be accountable for 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. You will establish appropriate metrics for measuring key project criteria and ensuring that project deliverables satisfy project requirements. The CQV Project Manager will also develop client relationships and act as Jacobs point of contact on project/client sites. You will seek new project opportunities for Jacobs.
• Bachelor’s degree in Mechanical, Chemical, or Electrical Engineering 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
• Flexibility and willingness to travel and work at various clients’ locations
Ideally, you’ll also have:
• Proposal development experience
• Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
• Knowledge of industry guidance:
o ISPE Baseline Guide 5 Commissioning and Qualification
o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
o ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
o ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
o ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
• Six Sigma Certification
