Computer System Validation (CSV) Engineer

Job Title: Computer System Validation (CSV) Engineer

Location: Boston, MA (Hybrid)

Duration: 12+ Months Contract

Position Summary

We are seeking an experienced Computer System Validation (CSV) Engineer to support validation and compliance activities for GxP-regulated computerized systems within a pharmaceutical/biotechnology manufacturing environment. The ideal candidate will have strong experience in FDA-regulated industries and hands-on expertise with validation lifecycle activities for manufacturing, laboratory, and quality systems.

Key Responsibilities

• Perform Computer System Validation (CSV) activities in compliance with FDA 21 CFR Part 11, GAMP 5, and cGMP regulations.
• Develop and execute validation documentation including Validation Plans, URS, FS, DS, IQ/OQ/PQ protocols, Traceability Matrix, and Validation Summary Reports.
• Support qualification and validation of computerized systems used in manufacturing, quality, laboratory, and automation environments.
• Review and approve system lifecycle documentation, SOPs, change controls, deviations, and CAPAs.
• Collaborate with Quality Assurance, IT, Engineering, Automation, Manufacturing, and Validation teams to ensure compliance and project execution.
• Support data integrity assessments and ensure systems comply with ALCOA+ principles.
• Participate in risk assessments and periodic reviews for validated systems.
• Support implementation and validation of systems such as LIMS, MES, SCADA, PLC, ERP, CMMS, and electronic quality management systems.
• Ensure validation deliverables are completed within project timelines.
• Provide audit support during internal, client, and regulatory inspections.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
• 5+ years of CSV experience within pharmaceutical, biotech, or medical device industries.
• Strong understanding of cGMP, FDA regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
• Experience with validation of GxP computerized systems and infrastructure qualification.
• Hands-on experience with validation documentation and execution.
• Knowledge of change control, deviation management, CAPA, and risk management processes.
• Excellent communication and cross-functional collaboration skills.

Preferred Skills

• Experience with systems such as TrackWise, Veeva, SAP, LabWare LIMS, DeltaV, Emerson Syncade, MasterControl, or Siemens platforms.
• Prior experience supporting manufacturing facilities, laboratories, or automation systems in pharma/biotech environments.
• Experience with cloud-based systems validation and data integrity initiatives is preferred.

Work Environment

• Pharmaceutical/biotech GMP-regulated environment.
• Hybrid or onsite role based in the Greater Boston/Cambridge, MA area.
• Ability to support occasional off-hours validation activities if required.