Jacobs Senior CQV Engineer in Cleveland, Ohio

Senior CQV Engineer

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.

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.

Technical/Functional Responsibilities:

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

#AF

#LifeSciences

Qualifications

Minimum Qualifications:

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

Preferred Qualifications:

  • Leadershipexperience

  • Asepticprocessing experience

  • Temperaturemapping experience

  • Cleaningvalidation experience

  • Processvalidation experience

  • Abilityto use test and measurement equipment (e.g., KAYE Validators)

  • Proposaldevelopment experience

  • 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-Ohio-Cleveland

Req ID: LIF00009X