Jacobs Computer Systems Validation Engineer in Summit, New Jersey

Computer Systems Validation 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.

Job Description

The Computer SystemValidation (CSV) Engineer will provide CSV services to clients in the LifeSciences Industry. The position provides an excellent opportunity to work for aGlobal Engineering Firm and support clients that manufacture life changingproducts. This position shall be responsible for the development and executionof CSV/CQV documentation on a variety of equipment, facilities, utilities,components, products, and computerized systems for a diverse client base ofbiotechnology, pharmaceutical, medical device, gene therapy and cell therapymanufacturers.

Technical/Functional Responsibilities:

ProvideCSV/CQV support to clients that manufacture GMP products on a consistent basisin conjunction with industry best practices:

  • DevelopCSV/CQV planning documents to manage CQV projects

  • Generateand execute CSV protocols (IQ/OQ/PQ) using Good Documentation Practices (GDPs)

  • Investigateand resolve protocol exceptions or discrepancies

  • Developtechnical reports and CSV summary reports

  • Startupequipment and systems in a safe and effective manner

  • DevelopGxP computer validation and CFR 21 Part 11 related documentation such asassessments, plans, URS, FRS and summary reports

  • Performrisk assessments and impact assessments

  • Applyengineering knowledge of, and experience with, manufacturing equipment, processequipment, HVAC, utilities, instrumentation, controls, and automation to supportclients

Qualifications

Minimum Qualifications:

Theideal candidate for this position will possess the following:

  • BS Electrical or Computer Engineering or equivalent

  • 8 -14 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

  • Knowledgeof US FDA (21 CFR 210, 211, 810) and EU EMEA regulations

  • Knowledgeof industry guidance:

  • ISPEBaseline Guide 5 Commissioning and Qualification

  • ISPEGAMP V, A Risk Based Approach to Compliant GMP Computerized Systems

  • ASTME2500 Standard Guide for Specification, Design, and Verification ofPharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

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

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

  • Six Sigma Certification

Candidatesmust have unrestricted rights to work in the U.S.

#AF

#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-New Jersey-Summit

Other Locations United States-Pennsylvania-Conshohocken

Req ID: LIF0000CJ