Forge Biologics

Forge Biologics

CSV Engineer I

Columbus, Ohio · Full-time

Sponsorship not specifiedDetected 63 days ago
ERPHRISGMPFDA RegulatoryPCRCRISPRMedical DevicesMass SpectrometryMentoringWritingNetSuiteGxP

About the role

  • 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).
  • By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.

Responsibilities

  • 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.
  • Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.

Requirements

  • Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivelant experience).
  • Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
  • Strong technical writing skills and ability to execute protocols with minimal supervision.
  • This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.
  • This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job.
  • 2+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
  • 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.
  • Ability to work onsite (in Columbus, Ohio) 3-4 days/week on average.
  • This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.

Nice to have

  • Preferred Skills:

Skills

  • 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.
  • Duties, responsibilities and activities may change, or new ones may be assigned.
  • Work Environment and Physical Demands
  • The employee will be stationary (standing/sitting) for extended periods of time.
  • Employees regularly wear personal protective equipment based on the task being performed.
  • Must be able to work in a confined space, such as a clean room or laboratory environment.
  • We've Got You Covered:
  • Health from day one

Compensation

  • We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:

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 - because rest fuels innovation.
  • 12 weeks of fully paid parental leave so you can focus on family when it matters most.
  • Annual bonus opportunities for all full-time team members.
  • Mental health counseling and financial planning services through our Employee Assistance Program.
  • Employer-paid short and long-term disability coverage to protect your peace of mind.
  • Onsite fitness facility at The Hearth.

Company info

  • to enable access to life-changing gene therapies and help bring them from ideas into reality.
  • We partner with scientists, physicians, biotech and pharma innovators, and patient communities - all united by one goal: improving lives.
  • If you're driven by purpose and excited to make a tangible impact, this is where your journey begins.
  • Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio.
  • Here, you won't just watch innovation happen - you'll be part of it.
  • Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases.
  • What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit.
  • We are open, creating a space where ideas flow freely, and every voice is valued.
  • We are purpose-driven, with every task directly tied to changing lives.
  • And we are engaged, energized by the challenges we face and the milestones we achieve together.
  • At Forge, your growth matters.
  • We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement.
  • Our people are our greatest investment, and we're proud to see team members grow with us.
  • If you're ready to use your talent to help deliver hope to patients around the world, join us - and be part of something bigger than yourself.
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This listing is sourced directly from Forge Biologics's careers page and normalized into a canonical job model.