CSV Engineer

Stryker Corporation; Northern (KY); On-site; Confidential; Full time

Job summary

Stryker Corporation in Hyde Park, OH, seeks a CSV Engineer to validate GxP computerized systems and support gene therapy manufacturing operations. You will lead validation activities for critical systems, ensuring data integrity and regulatory compliance.

Responsibilities include authoring and reviewing validation deliverables, applying risk-based validation, and collaborating with IT, QA, Lab Ops, and Facilities to maintain validated state.

Qualifications

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field.
• 5–7 years of experience in Computer System Validation (CSV) within a GxP regulated environment.
• Experience validating systems such as Veeva Vault QMS, BMRAM, laboratory instruments, or Metasys.
• Strong technical writing skills and ability to execute protocols with minimal supervision.

Responsibilities

• Author, review, and execute validation deliverables for GxP computerized systems, including IQ/OQ/PQ protocols and validation summaries.
• Support CSV efforts for Veeva Vault QMS, BMRAM, laboratory instrumentation, and ERP (NetSuite).
• Perform risk assessments to determine validation approach and ensure testing of data integrity and audit trails.
• Collaborate with IT, QA, Lab Operations, and Facilities to support system upgrades and changes while maintaining validated state.

Skills

GxP compliance

Technical writing

Validation planning

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field

Tools

Veeva Vault QMS

BMRAM

Metasys

Analytical lab instruments (HPLC, UHPLC, PCR)

ERP System NetSuite

Job description

CSV EngineerKatalyst Healthcares and LifesciencesHyde Park, OH, United States**Description**Job Description: The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site 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 Client. By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness. Roles & Responsibilities: uthor, 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. Support 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 a validated state. Requirements: Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience). 5-7 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 (Client) like Metasys. Strong technical writing skills and ability to execute protocols with minimal supervision. Nice to have: BMRAM and analytical lab instruments experience.