Jacobs Senior CQV Engineer in Kalamazoo, Michigan
Senior CQV Engineer
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.
The Commissioning,Qualification and Validation (CQV) Engineer 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 position shall be responsible for the developmentand execution of CQV documentation on a variety of equipment, facilities,utilities, components, products, and systems for a diverse client base ofbiotechnology, pharmaceutical, medical device, gene therapy and cell therapymanufacturers.
ProvideCQV support to clients that manufacture GMP products on a consistent basis inconjunction with industry best practices:
DevelopCQV planning documents to manage CQV projects
Generateand execute CQV protocols using Good Documentation Practices (GDPs)
Investigateand resolve protocol exceptions or discrepancies
Developtechnical reports and CQV summary reports
Startupequipment in a safe and effective manner
Readand verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.)
DevelopStandard Operating Procedures (SOPs), process workflows, Validation MasterPlans, User Requirement Specifications, Turnover Packages, and other regulatorysupport documentation
Performrisk assessments and impact assessments
Applyengineering knowledge of, and experience with, manufacturing equipment, processequipment, HVAC, utilities, instrumentation, controls, and automation to supportclients
Theideal candidate for this position will possess the following:
BS in Mechanical, Chemical or Electrical Engineering or equivalent
15 years of CQV experience in the life sciences industry
Understanding of Good Manufacturing Practices (GMPs)
Technical writing skills
Proficient with Microsoft Office – Word, Excel, PowerPoint, Project
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
Abilityto use test and measurement equipment (e.g., KAYE Validators)
Knowledgeof US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
Knowledgeof industry guidance:
üISPEBaseline Guide 5 Commissioning and Qualification
üISPEGAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
üASTME2500 Standard Guide for Specification, Design, and Verification ofPharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
üISPEGuideline: Science and Risk-based Approach for the Delivery of Facilities,Systems, and Equipment, 2011
üISPEGood Practice Guide: Applied Risk Management for Commissioning andQualification, 2011
- Six Sigma Certification
Candidatesmust have unrestricted rights to work in the U.S.
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.
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-Michigan-Kalamazoo
Req ID: LIF00005M