Senior CSV Engineer / Senior Validation Engineer

About the Role

We are seeking a Senior CSV Engineer / Senior Validation Engineer with 7+ years of experience in Computer System Validation (CSV) and Computer Software Assurance (CSA) within FDA-regulated pharmaceutical or biotechnology environments. This role will lead validation activities for standalone GMP manufacturing equipment in a single-use manufacturing facility, ensuring compliance with regulatory requirements and collaborating with Engineering, CQV, Automation, Quality, IT, and equipment vendors.

Responsibilities

• Lead CSV/CSA activities for standalone GMP manufacturing equipment.
• Develop validation strategies, Validation Plans, Risk Assessments, and validation documentation.
• Review URS, Functional Specifications, Design Documents, and system architecture.
• Author and execute IQ/OQ protocols, Traceability Matrix, and Validation Summary Reports.
• Review vendor FAT, SAT, IQ, and OQ documentation for leveraged testing.
• Validate user access, audit trails, electronic records, electronic signatures, alarms, reports, and software configurations.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity (ALCOA+) requirements.
• Manage deviations, CAPAs, change controls, and support SOP development and system release.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related field.
• 7+ years of CSV/CSA experience in GMP-regulated pharmaceutical or biotechnology environments.
• Hands-on experience validating standalone GMP manufacturing equipment.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity principles.
• Experience with validation lifecycle documentation, risk-based testing, and vendor documentation review.
• Strong communication and cross-functional collaboration skills.

Preferred Qualifications

• Experience with UNICORN, KlariFi, or Lucullus.
• Experience with chromatography, TFF, bioreactors, or other bioprocess equipment.
• Familiarity with PLC/HMI, SCADA systems, and Kneat.
• Experience supporting new equipment installation and capital projects.

Location: Devens, Massachusetts | Employment Type: Contract