CSV Engineer

Katalyst CRO; Woburn (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a Computer System Validation (CSV) Engineer with experience in 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.

Develop, execute, and maintain CSV documentation and validation protocols for QC laboratory systems

Qualifications

• Bachelor's degree in engineering, CS, life sciences, pharmacy, or biotech.
• Experience in CSV within GMP pharma/biotech environment.
• Strong knowledge of GAMP 5 and 21 CFR Part 11.
• Hands-on validation of QC laboratory and manufacturing systems.
• Excellent writing, communication and problem-solving skills.

Responsibilities

• Develop, execute, and maintain CSV documentation and validation protocols for QC laboratory systems and manufacturing systems.
• Support the complete validation lifecycle: URS, IQ, OQ, 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 for accuracy, completeness, and regulatory compliance.
• Collaborate with 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.

Skills

CSV lifecycle understanding

Technical writing

Regulatory compliance

Cross-functional collaboration

Risk assessment

Education

Bachelor's degree in engineering or related field

Tools

URS/IQ/OQ/PQ templates

Validation protocols

Job description

• 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.
• 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.

Job Summary

• 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.