Verista · 4 hours ago
5910 - CSV Engineer / Validation Engineer
Kalamazoo, MI
Full-time
Onsite
Mid Level
$65K/yr - $110K/yr
3+ years expVerista is a company that partners with leading brands in the life science industry to address significant healthcare challenges. They are seeking a Validation Engineer to execute Computer System Validation activities, support the development of validation deliverables, and collaborate with various teams to ensure compliance and data integrity in EBR systems.
ComplianceHealth CareLife ScienceManufacturingPharmaceutical
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
Qualification
Required
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
Benefits
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
Company
Verista
Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.
501-1000 employees
H1B Sponsorship
Verista has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (13)
2022 (6)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Bill Murray
Chief Financial Officer
Dan White
Chief Operating Officer
Recent News
2023-12-22
2023-12-22
Company data provided by crunchbase