Senior CQV Engineer in Summit, Union County, New Jersey, United States

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 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 position shall be responsible for the development and execution of 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.

  


  

Technical/Functional Responsibilities:

  

Provide CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices:

  

  

•         Develop CQV planning documents to manage CQV projects

  

•         Generate and execute CQV protocols using Good Documentation Practices (GDPs)

  

•         Investigate and resolve protocol exceptions or discrepancies

  

•         Develop technical reports and CQV summary reports

  

•         Startup equipment in a safe and effective manner

  

•         Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.)

  

•         Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation

  

•         Perform risk assessments and impact assessments

  

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



#AF#LifeSciences

Minimum Qualifications:

  

The ideal 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 members ideas and opinions and  work through conflicts or disagreements
  •  
  

 

  

Preferred Qualifications:

•         Leadership experience

•         Aseptic processing experience

•         Temperature mapping experience

•         Cleaning validation experience

•         Process validation experience

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

•         Proposal development experience

•         Knowledge of US FDA (21 CFR <phone number removed> ) and EU EMEA regulations

•         Knowledge of industry guidance:

ü  ISPE Baseline Guide 5 Commissioning and Qualification

ü  ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems

ü  ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ü  ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011

ü  ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011

     
  • Six Sigma  Certification
  •  
  

Candidates must 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.

About Jacobs

Jacobs leads the global professional services sector delivering solutions for a more connected, sustainable world.

With $15.0 billion in combined revenue and a talent force more than 77,000 strong, Jacobs provides a full spectrum of services including scientific, technical, professional, construction- and program-management for business, industrial, commercial, government and infrastructure sectors.

For more information, visit <web address removed>

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