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The Commissioning, Qualification and Validation (CQV) Regional Manager will provide CQV services to clients in the Life Sciences Industry. The position provides an excellent opportunity to work for a Global Engineering Firm and support clients that manufacture life changing products. This hands-on regional director position shall be responsible for managing the development and execution of start-up and CQV documentation on a variety of equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.

• Develop CQV planning documents to manage CQV projects

• Perform risk assessments and impact assessments

• Lead the team in generating and executing CQV protocols using Good Documentation Practices (GDPs)

• Lead the team in investigating and resolving protocol exceptions or discrepancies

• Lead the team in developing technical reports and CQV summary reports

• Lead the team in startup of equipment in a safe and effective manner

• Ability to manage CQV staff members

• Establish appropriate procedures regarding handover of systems from construction to C&Q team as well as handover of systems from C&Q team to client

• Establish appropriate metrics for measuring key project criteria

• Ensure that project deliverables satisfy project requirements

• Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients

• BS in Mechanical, Chemical or Electrical Engineering or equivalent experience in lieu of degree

• 8+ 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

• Experience with tracking progress according to schedules and cost estimates

• Experience with training and mentoring staff members

• Flexibility and willingness to travel and work at various clients’ locations

• Ability to work well with diverse, multi-disciplined groups

• Ability to effectively communicate with management and fellow project team members

• Ability to negotiate/compromise with other project team members to achieve project goals

• Ability to listen and respect fellow project team member’s ideas and opinions and work through conflicts or disagreements

Ideally, you’ll 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

#LifeSciences, #Bio/Pharma, #EPCMV, #globallifescience

#LI-SH1

Jacobs is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law. Learn more about your rights under Federal EEO laws and supplemental language.