• Computer System Validation Engineer Jobs in United States Of America

  • Jacobs Engineering Group Inc.
  • United States Of America, Usa

Job Description:

Computer System Validation Engineer - ( LIF0000VU )


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 facilitys entire life cycle

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


Minimum Qualifications

The ideal candidate for this position will possess the following

BS Electrical or Computer Engineering or equivalent
4-14 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 members 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

ISPE Baseline Guide 5 Commissioning and Qualification

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

ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical 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

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 youll find a flourishing career here at Jacobs

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Engineering/Projects, Consulting Services
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 08th Apr 2020

Key Skills:

Company Profile:

Jacobs Engineering Group Inc



Company Turnover
10000 10000+ Crores

Company Size
10001 10001+ Employees

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