CSV Engineer I
Forge Biologics•Columbus, OH
•Hybrid
About The Position
The CSV Engineer I is responsible for ensuring that GxP computerized systems at Forge Biologics are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). This role directly supports gene therapy manufacturing operations by leading validation activities for key systems including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys BMS. By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.
Requirements
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field (or equivelant experience).
- 2+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
- Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
- Experience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (BMS) like Metasys.
- Strong technical writing skills and ability to execute protocols with minimal supervision.
- Ability to work onsite (in Columbus, Ohio) 3-4 days/week on average.
Nice To Haves
- Experience with Veeva Vault platform (QMS or QualityDocs) and BMRAM configuration or validation.
- Hands-on validation of laboratory instruments (e.g., HPLC, UV-Vis,)including software like Empower or Chromeleon.
- Familiarity with Metasys BMS or similar environmental monitoring systems in a GxP facility.
- Experience with electronic execution systems such as Veeva Vault Manager or similar.
- Experience supporting regulatory inspections (FDA, EMA) and responding to CSV-related observations.
Responsibilities
- Author, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.
- Supports computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc), ERP System (NetSuite).
- Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.
- Manage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge’s quality system.
- Collaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining validated state.
Benefits
- Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
- A competitive paid time off plan
- 12 weeks of fully paid parental leave
- Annual bonus opportunities for all full-time team members.
- 401(k) with company match
- Special employee discounts, including childcare and dependent care savings.
- Onsite fitness facility at The Hearth.
- Mental health counseling and financial planning services through our Employee Assistance Program.
- Employer-paid short and long-term disability coverage
- A fully stocked kitchen with free snacks and beverages
- Ongoing professional development resources, training, and mentorship programs
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
