CSV Consultant
Job in
Framingham, Middlesex County, Massachusetts, 01704, USA
Listed on 2026-02-16
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-02-16
Job specializations:
-
Quality Assurance - QA/QC
-
Engineering
Job Description & How to Apply Below
Responsibilities
- Validate and maintain cloud-based enterprise systems including Oracle Fusion Cloud ERP, serialization platforms (Tracelink, Antares), and electronic quality management systems
- Implement and validate Electronic Batch Record (E ) systems such as Master Control
- Support serialization system validation for end-to-end drug product shipping in compliance with DSCSA regulations
- Validate data migrations and integrations between enterprise systems (Oracle, Cardinal Health, Azure)
- Perform release impact assessments and testing for SaaS system updates
- Drive Computer Software Assurance (CSA)-based validation approaches for cloud systems
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment
- Conduct Configuration Specification Verifications and periodic reviews for Autoclaves, Bioreactors, HPLCs, and other critical systems
- Qualify cell therapy and manufacturing equipment including controlled rate freezers, flow cytometers, and production systems
- Support commissioning and qualification of facilities, utilities, and Building Automation Systems (Client)
- Validation Documentation & Compliance:
- Author and execute validation protocols including Validation Plans, URS, FRS, IQ/OQ/PQ, RTM, and Validation Summary Reports
- Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA++ data integrity principles
- Support change control management, deviations, and CAPA processes in GxP environments
- Perform SOP mapping and business process documentation for system implementations
- Maintain validation documentation in Electronic Document Management Systems (EDMS)
- Support regulatory inspection readiness by ensuring validation documentation is audit‑ready
- Participate in internal and external audits, providing validation evidence and technical expertise
- Conduct data integrity assessments and implement controls to maintain compliance
- Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field
- 5‑8+ years of hands‑on Computer Systems Validation experience in pharmaceutical, biotechnology, or medical device industries
- Strong experience with Oracle Fusion Cloud ERP or similar enterprise ERP systems (SAP, Oracle E‑Business Suite)
- Experience validating serialization systems (Tracelink, Antares) and DSCSA compliance highly preferred
- Hands‑on experience with SaaS/cloud‑based system validation and CSA approaches
- Equipment qualification experience (autoclaves, bioreactors, HPLCs, manufacturing equipment)
- Proficiency with electronic quality systems (Master Control, Veeva Vault, Track Wise, ZenQMS)
- LIMS validation experience (Lab Ware, Lab Vantage, Empower)
- Strong knowledge of GAMP 5, 21 CFR Part 11, GxP, and data integrity principles
- Proven ability to author, review, and execute IQ/OQ/PQ protocols independently
- Strong understanding of risk‑based validation and Computer Software Assurance (CSA)
- Experience with change control, deviation management, and CAPA processes
- Excellent documentation skills and attention to detail
- Strong communication and collaboration skills with cross‑functional teams
- Ability to manage multiple priorities in a fast‑paced GMP environment
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