Sr. CSV Engineer
Posted on: 27 Jan 2021
Kalamazoo, MI
Job Description
Description
Here at Jacobs, we apply our expertise and knowledge as we look into the future with great optimism and focus. We don't settle until we give our best and know that we're making a difference.
As a Computer System Validation (CSV) Engineer, you'll join our collaborative team providing CSV/CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices. We are looking for a passionate CSV Engineer who is driven by collaboration, exceeding expectations, and challenging the status quo.
You'll be accountable for developing CSV/CQV planning documents to manage CQV projects, generating and executing CSV protocols (IQ/OQ/PQ) using Good Documentation Practices (GDPs), investigating and resolving protocols exceptions or discrepancies, developing technical reports and CSV summary reports, and starting up equipment in a safe and effective manner; as well as performing risk assessments and impact assessments. You'll also be accountable for developing GxP computer validation and CFR 21 Part 11 related documentation such as assessments, plans, URS, FRS, and summary reports.
Bring your curiosity, talent for multi-tasking and collaboration, and extreme organizational skills and we'll help you grow, pursue and fulfill what drives you - so we can make big impacts on the world, together.
QUALIFICATIONS
Bachelor's degree in Electrical or Computer Engineering or equivalent
At least 8 years of CSV experience in the Life Sciences industry
Understanding of Good Manufacturing Practices (GMPs)
Strong technical writing skills
Proficient with Microsoft Office - Word, Excel, PowerPoint, Project
Flexibility and willingness to travel and work at various clients' locations
Ideally, you'll also have:
Experience with qualifying SCADA, Delta V, BAS and BMS systems
Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
Knowledge of industry guidance:
oISPE Baseline Guide 5 Commissioning and Qualification
oISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
oASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
oISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
oISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
Six Sigma Certification
LifeSciences AF
Jacobs Engineering
Dallas, TX
Jacobs Engineering Group Inc. provides technical, professional, and construction services. The company’s Aerospace, Technology, Environmental and Nuclear segment offers scientific, engineering, construction, nuclear, environmental, and technical support services to the aerospace, defense, technical, and automotive industries. Its Buildings, Infrastructure and Advanced Facilities segment develops/rehabilitates plans for highways, bridges, transit, tunnels, airports, railroads, intermodal facilities, and maritime or port projects; develops or rehabilitates critical water resource systems, water/wastewater conveyance systems, and flood defense projects; and provides engineering design, construction management, design build, and operations and maintenance.
This segment also designs and constructs buildings; offers consulting, engineering, procurement, construction management, and delivery services for life sciences clients; and provides services relating to modular construction and other consulting and strategic planning services, as well as offers services in containment, barrier technology, locally controlled environments, building systems automation, off-the-site design, and fabrication of facility modules.
The company’s Energy, Chemicals and Resources segment offers services relating to onshore and offshore oil and gas production facilities, processing facilities, gathering systems, and transmission pipelines and terminals; feasibility/economic studies, technology evaluation, conceptual engineering, front end loading, detailed engineering, procurement, construction, maintenance, and commissioning services; and engineering, procurement, and construction solutions.
This segment also provides services, such as manufacturing complex, expansions, modifications, and management of plant relocations; construction management and field construction services; and services to operate and maintain facilities. The company was founded in 1947 and is headquartered in Dallas, Texas.
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IndustryConstruction
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No. of Employees74, 400
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Website
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Jobs Posted934
