Lead Mechanical Engineer Gus Perdikakis Associates
Cincinnati, OH26 days ago
- $110,000–$135,000 Per Year
- Full-time
- Employee
Want to know if you’re a fit?
Upload your resume and let our AI show you.
Upload your resume and let our AI show you.
Skills
- Analysis Skillsunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Change Controlunmatched
- Change Managementunmatched
- Code of Federal Regulationsunmatched
- Computer Scienceunmatched
- Computer Skillsunmatched
- Computer Systemsunmatched
- Data Qualityunmatched
- ERP (Enterprise Resource Planning)unmatched
- Functional Testingunmatched
- Gene Therapyunmatched
- GxPunmatched
- High Performance Liquid Chromatography (HPLC)unmatched
- Instrumentationunmatched
- Laboratoryunmatched
- Laboratory Information Management System (LIMS)unmatched
- Laboratory Operationsunmatched
- Maintain Complianceunmatched
- Manufacturing Operationsunmatched
- Medical Equipmentunmatched
- NetSuiteunmatched
- Patient Safetyunmatched
- Polymerase Chain Reaction (PCR)unmatched
- Process Validationunmatched
- Property Managementunmatched
- Quality Assuranceunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Requirements Validation/Verificationunmatched
- Risk Analysisunmatched
- Software Patchesunmatched
- System Validationunmatched
- Systems Administration/Managementunmatched
- Technical Writingunmatched
- Validation Planunmatched
- Writing Skillsunmatched
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.
- 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.
- 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.
- 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.
Numbers & Facts
| Location | Cincinnati, OH |
Similar Jobs
- New!
Hydraulic Systems Engineer Jobot
Cincinnati, OH6 days ago- $85,000–$120,000 Per Hour
- New!
Senior Mechanical Design Engineer Jobot
Cincinnati, OH6 days ago- $100,000–$120,000 Per Year
- New!
Senior Mechanical Engineer UCE Gables Search Group
Cincinnati, OH1 day ago- $115,000–$173,000 Per Year
- New!
Hardware Design Engineer - Aerospace Industry Jobot
West Chester, OH5 days ago- $100,000–$110,000 Per Year
- New!
Manufacturing Applications Engineer Jobot
Cincinnati, OH2 days ago- $75,000–$100,000 Per Year