What are the responsibilities and job description for the CSV Engineer position at Katalyst Healthcares and Lifesciences?
Job Summary:
Roles & Responsibilities:
Requirements / Qualifications:
- We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment.
- The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance.
Roles & Responsibilities:
- Develop, execute, and maintain Computer System Validation (CSV) documentation and validation protocols for QC laboratory systems and manufacturing systems.
- Support the complete validation lifecycle, including preparation, execution, review, and approval of User Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Risk Assessments, and Validation Reports.
- Perform risk assessments to identify and mitigate validation and compliance risks.
- Ensure compliance with GAMP 5, 21 CFR Part 11, GMP, and internal quality standards.
- Review validation documentation to ensure accuracy, completeness, and regulatory compliance.
- Collaborate with Quality Assurance (QA), Manufacturing, Engineering, and IT teams to support validation activities and system implementations.
- Provide validation support for QC laboratory systems and manufacturing equipment throughout their lifecycle.
- Assist with change control, deviation investigations, and periodic reviews related to validated systems.
- Maintain accurate validation records and ensure documentation is audit ready.
- Support internal and external regulatory inspections by providing validation documentation and technical expertise.
Requirements / Qualifications:
- Bachelor's degree in engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or a related field.
- Experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment.
- Strong knowledge of GAMP 5, 21 CFR Part 11, and GMP regulations.
- Hands-on experience supporting QC laboratory systems and/or manufacturing equipment validation.
- Experience developing and reviewing validation lifecycle documentation, including URS, IQ, OQ, PQ, Risk Assessments, and Validation Reports.
- Experience working collaboratively with Quality Assurance (QA), Manufacturing, Engineering, and IT teams.
- Strong understanding of the CSV lifecycle, risk-based validation, and documentation best practices.
- Excellent technical writing, documentation, communication, and problem-solving skills.
- Ability to manage multiple validation activities while maintaining compliance with regulatory and quality requirements.