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Director Computer System Validation Csv Jobs in Michigan

Lancesoft

Manufacturing Engineer II - Exempt

Dexter, MI · On-site

$45 - $50/hr

Computer System Validation (CSV) * Manufacturing, Packaging, and Laboratory Equipment * Technical experience (Troubleshooting) or any similar experience or background * Quality / Process Control ...

Biovire

Manager of Validation

Brighton, MI · On-site

... CQV), and Computer System Validation (CSV) area. Ensures that all equipment, facilities, and ... competence within direct reports WORK EXPERIENCE AND education requirements This is a key ...

Biovire

Head of Validation

Brighton, MI · On-site

... and computer system validation (CSV) activities across the Brighton site. This role provides ... Direct impact supporting operational readiness and future commercialization * Company-paid medical ...

Biovire

Manager of Validation

Brighton, MI · On-site

... CQV), and Computer System Validation (CSV) area. Ensures that all equipment, facilities, and ... competence within direct reports WORK EXPERIENCE AND education requirements This is a key ...

Biovire

Head of Validation

Brighton, MI

... and computer system validation (CSV) activities across the Brighton site. This role provides ... Direct impact supporting operational readiness and future commercialization * Company-paid medical ...

BoehringerPRD

... computer system and computerized equipment validation within BIAH Operations, including program ... Understands content and compliance requirements for related CSV deliverables and uses this ...

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5910 - CSV Engineer / Validation Engineer

5910 - CSV Engineer / Validation Engineer

Verista, Inc.

Kalamazoo, MI • On-site, Remote

Other

Posted 25 days ago

Job description

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.

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