Jacobs CSV Engineer in Kalamazoo, Michigan
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.
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.
Here’s What You’ll Need:
•Bachelor’s degree in Electrical or Computer Engineering or equivalent
•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
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 (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) and supplemental language. (https://www.eeoc.gov/sites/default/files/migrated_files/employers/eeoc_gina_supplement.pdf)
At Jacobs, we’re challenging today to reinvent tomorrow by solving the world’s most critical problems for thriving cities, resilient environments, mission-critical outcomes, operational advancement, scientific discovery and cutting-edge manufacturing, turning abstract ideas into realities that transform the world for good. With $13 billion in revenue and a talent force of more than 55,000, Jacobs provides a full spectrum of professional services including consulting, technical, scientific and project delivery for the government and private sector.
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