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Form of workHere at Jacobs, we apply our expertise and knowledge as we look into the future with great optimism and focus. We don't settle until we give our best and know that we're making a difference.
As a Sr. Commissioning, Qualification, and Validation (CQV) Lead, you'll join our collaborative team providing CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices. We are looking for a passionate Senior CQV Lead who is driven by collaboration, exceeding expectations, and challenging the status quo.
You'll be accountable for providing Quality management and oversight of the design and qualification activities, developing and maintaining the project quality activity plan, driving the quality activities during the project execution phase from design through construction, verification, and system release. You will also be tasked with supporting the science and risk-based qualification and validation activities, supporting the execution and reporting of the commissioning and qualification activities, preparing or reviewing all documentation where required specific to quality activities, ensuring any deviations are thoroughly investigated and closed in a timely manner, and training project members in science and risk-based approach to validation
Bring your curiosity, talent for multi-tasking and collaboration, and extreme organizational skills and we'll help you grow, pursue and fulfill what drives you - so we can make big impacts on the world, together.
• Bachelor's degree in Mechanical, Chemical, or Electrical Engineering or equivalent years of experience in lieu of degree
• 8+ years of CQV experience in the Life Sciences industry preferred
• Understanding of Good Manufacturing Practices (GMPs)
• Strong technical writing skills
• Proficient with Microsoft Office - Word, Excel, PowerPoint, Project
• Flexibility and willingness to travel and work at various clients' locations
• Significant experience from a similar position within project execution the pharmaceutical or life-sciences industry.
• Strong experience with Commissioning, Qualification and Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility.
• Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500.
• Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15.
• Knowledge and understanding of EU and US cGMP regulations.
• Track record of utilizing Risk Based Approaches to Qualification / Validation activities.
• Strong track record of identifying, escalating, and correcting compliance issues and implementing process improvements.
• Strong experience with establishing and leading FAT and SAT activities
*This position will require fulltime presence in Indianapolis during the Design phase and then fulltime present in Lafayette, IN during the Construction/Verification phase.
Ideally, you'll also have:
• 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
#LifeSciences, #Bio/Pharma, #EPCMV, #globallifescience, #CQV
