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CQV Project Manager

Jacobs serves the PharmaBio, Chemicals, Refining, Pulp & Paper, Power & Utilities, High Tech and Consumer Products Industries. Our core life sciences network has contributed to becoming the largest provider of engineering and construction services to pharmaceutical and biotechnology clients and we have established ourselves as the center of excellence for Pulp and Paper facilities. Jacobs provides full-service engineering, procurement, and construction management services for both new and existing facilities, offering environmental and water / wastewater support, energy audits, and hygienic / sanitary assessments. For projects of every scale we provide design, engineering, construction, commissioning, and maintenance services that support a facility's entire life cycle.
Position Summary
The Commissioning,Qualification and Validation (CQV) Project Manager will provide CQV services toclients in the Life Sciences Industry. The position provides an excellentopportunity to work for a Global Engineering Firm and support clients thatmanufacture life changing products. This hands-on project manager positionshall be responsible for managing the development and execution of CQV documentationon a variety of equipment, facilities, utilities, components, products, andsystems for a diverse client base of biotechnology, pharmaceutical, medicaldevice, gene therapy and cell therapy manufacturers.
DevelopCQV planning documents to manage CQV projects
Perform riskassessments and impact assessments
Leadthe team in generatingand executing CQV protocols using Good Documentation Practices (GDPs)
Lead the team inInvestigating and resolving protocol exceptions or discrepancies
Lead the team indeveloping technical reports and CQV summary reports
Lead the team instartup of equipment in a safe and effective manner
Establish appropriateprocedures regarding handover of systems from construction to C&Q team aswell as handover of systems from C&Q team to client
Establish appropriatemetrics for measuring key project criteria
Ensure that projectdeliverables satisfy project requirements
Apply engineeringknowledge of, and experience with, manufacturing equipment, process equipment,HVAC, utilities, instrumentation, controls, and automation to support clients
BSin Mechanical, Chemical or Electrical Engineering or equivalent
15 years of CQV experience in the life sciences industry
Strongworking knowledge of commissioning, qualification and validation deliverables,team building and client relationship building
LeadershipExperience
Experiencewith tracking progress according to schedules and cost estimates
Experiencewith training and mentoring junior staff members
Flexibilityand willingness to travel and work at various clients' locations
Abilityto work well with diverse, multi-disciplined groups
Abilityto effectively communicate with management and fellow project team members
Abilityto negotiate/compromise with other project team members to achieve projectgoals
Abilityto listen and respect fellow project team member's ideas and opinions and workthrough conflicts or disagreements
Preferred Qualifications:
Proposal developmentexperience
Knowledge of US FDA (21CFR 210, 211, 810) and EU EMEA regulations
Knowledge of industryguidance:
ISPE Baseline Guide 5Commissioning and Qualification
ISPE GAMP V, A RiskBased Approach to Compliant GMP Computerized Systems
ASTM E2500 StandardGuide for Specification, Design, and Verification of Pharmaceutical andBiopharmaceutical Manufacturing Systems and Equipment
ISPEGuideline: Science and Risk-based Approach for the Delivery of Facilities,Systems, and Equipment, 2011
ISPEGood Practice Guide: Applied Risk Management for Commissioning andQualification, 2011
SixSigma Certification
At Jacobs, we help prepare people for new opportunities and challenges. With positions at every level, openings in multiple disciplines, expertise in a range of markets and offices around the globe, we create an environment where you can learn, grow, and thrive. From our competitive benefits program to our Health and Safety initiative of Beyond Zero workplace injuries, we believe that you'll find a flourishing career here at Jacobs.
#LifeSciences


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