5910 - CSV Engineer / Validation Engineer
External
Veristainc · Kalamazoo, MIPrepare for this interview
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About the role
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Validation Engineer Responsibilities: Execute Computer System Validation activities for Electronic Batch Record (EBR) systems supporting aseptic fill operations in compliance with cGMP, 21 CFR Part 11, and EU Annex 11 Support development and review of validation deliverables including URS, FDS, risk assessments, and validation plans in alignment with GAMP 5 principles Collaborate with Operations, Quality, Engineering, IT, and Automation teams to define system requirements, intended use, and validation scope Participate in execution and documentation of validation testing (IQ, OQ, PQ), including deviation tracking and resolution support Support validation of interfaces between PLC/SCADA systems and MES/EBR platforms to ensure data integrity and accurate batch execution Maintain organized, inspection-ready validation documentation and support change control and periodic review activities for validated EBR systems
Requirements
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical field
- 3+ years of hands-on Computer System Validation (CSV) experience in a regulated pharmaceutical or biotechnology environment, supporting MES and/or Electronic Batch Record (EBR) systems
- Working knowledge of cGMP regulations, including 21 CFR Part 11 and EU Annex 11, and application of GAMP 5 principles across the system lifecycle
- Experience supporting validation documentation and testing activities (URS, FDS, risk assessments, IQ/OQ/PQ) and managing deviations and change controls
- Ability to collaborate effectively with cross-functional teams (Operations, Quality, Engineering, IT, Automation) and support system interfaces with PLC/SCADA-controlled equipment
- Ability to travel/be on-site up to 25% of the time in Kalamazoo, MI. This role can be 75% remote.
- *Verista is an equal opportunity employer.
- National (US) Range
- $65,000 - $90,000 USD
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