Jacobs CQV Project Manager in Athens, Georgia

CQV Project Manager

Description

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 ingeneratingand 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

Qualifications

  • 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

Jacobs is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. Jacobs is a background screening, drug-free workplace.

Primary Location United States-Georgia-Athens

Other Locations United States-Pennsylvania-Conshohocken

Req ID: LIF0000CR