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CSV Engineer / Validation Engineer

Verista Inc.Kalamazoo, MI
On-site Full-time $65K/yr - $90K/yr

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Experience Level

Experience

Qualifications

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...

About the job

Description

Verista unites a team of 500 experts with the world’s leading brands in the life sciences sector, addressing their business needs. Our mission is to foster growth and innovation within the scientific community, assisting researchers, organizations, and companies in tackling some of the most urgent healthcare challenges globally. Verista delivers cutting-edge solutions and services that promote informed decision-making, fueled by our substantial investment in our people and capabilities.

Our growth is propelled by exceptional individuals who excel in collaborative environments and share our commitment to empowering life science clients to enhance lives. Our dedicated professionals strive to make a meaningful impact every day.

Company Culture Guidelines & Values:

  • We empower and support our colleagues.
  • We are committed to client success in every interaction.
  • We have the courage to do what is right.
  • We promote an inclusive environment where everyone feels respected, engaged, and challenged.
  • We continuously acquire new skills and learn from our experiences to enhance our collective expertise.

Validation Engineer Responsibilities:

  • Conduct Computer System Validation activities for Electronic Batch Record (EBR) systems that support aseptic fill operations, ensuring compliance with cGMP, 21 CFR Part 11, and EU Annex 11.
  • Assist in the development and review of validation deliverables, including User Requirement Specifications (URS), Functional Design Specifications (FDS), risk assessments, and validation plans, in accordance with GAMP 5 principles.
  • Collaborate with Operations, Quality, Engineering, IT, and Automation teams to define system requirements, intended use, and validation scope.
  • Participate in the execution and documentation of validation testing (IQ, OQ, PQ), including deviation tracking and resolution support.
  • Support the validation of interfaces between PLC/SCADA systems and MES/EBR platforms, ensuring data integrity and accurate batch execution.
  • Maintain organized, inspection-ready validation documentation and assist with change control and periodic review activities for validated EBR systems.

About Verista Inc.

Verista is a leading provider of innovative solutions and services, dedicated to empowering the life sciences sector. Our expert team collaborates with top-tier organizations to address critical healthcare challenges and to enhance decision-making through our extensive knowledge and capabilities.

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