Sr. Computer System Validation Engineer - (LIF000134)

  • Jacobs
  • Primary Location: United States-Michigan-Kalamazoo-US MI Kalamazoo
  • Nov 26, 2020
Full time Construction

Job Description

Our People & Places Solutions business – reinforces our drive to improve the lives of people everywhere and epitomizes the "why" of what we do – the tremendous positive impact and value our solutions bring to our communities and society as a whole. From facilities delivering life-saving therapies and ensuring clean water to enabling the connection of people through all modes of transportation and providing access to technology – we're integrating a multitude of these solution elements to build the smart environments of tomorrow.

Start your Jacobs career with a company that inspires and empowers you to deliver your best work so you can evolve, grow and succeed – today and into tomorrow.

The Computer System Validation (CSV) Engineer will provide CSV 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 CSV/CQV documentation on a variety of equipment, facilities, utilities, components, products, and computerized systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.

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

  • Develop CSV/CQV planning documents to manage CQV projects
  • Generate and execute CSV protocols (IQ/OQ/PQ) using Good Documentation Practices (GDPs)
  • Investigate and resolve protocol exceptions or discrepancies
  • Develop technical reports and CSV summary reports
  • Startup equipment and systems in a safe and effective manner
  • Develop GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS and summary reports
  • 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
 The ideal candidate for this position will possess the following:
  • BS Electrical or Computer Engineering or equivalent
  • 15+ years of CSV 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:
  • Experience with qualifying SCADA systems
  • Experience with qualifying Delta V systems
  • Experience with qualifying BAS and BMS system
  • Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
  • Knowledge of industry guidance:
o ISPE Baseline Guide 5 Commissioning and Qualification
o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
o ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
o ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
o ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
  • Six Sigma Certification
 Jacobs is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law. Learn more about your rights under Federal EEO laws and supplemental language. 

Primary Location

: United States-Michigan-Kalamazoo-US MI Kalamazoo

Job Posting

: Nov 18, 2020, 10:08:54 PM


: Engineering



Job Type

: Experienced
Job Classification: Full-Time Regular

Work Locations

US MI Kalamazoo 
 Kalamazoo 49001
Capabilities: Life Sciences and Biopharma