Senior CSV Engineer

About the Role

We are looking for a seasoned Senior CSV (Computer System Validation) Engineer to lead validation and compliance efforts in a major pharmaceutical manufacturing and capital project setting. This pivotal role involves ensuring that computerized systems are developed, implemented, and maintained in strict accordance with GMP, GAMP 5, data integrity standards, and relevant regulatory frameworks.

The position is ideal for experienced CSV professionals with a solid background in pharmaceutical, biotechnology, or other strictly regulated manufacturing sectors.

Key Responsibilities

• Lead and perform all CSV activities across manufacturing, labs, automation, engineering, and business systems.
• Create, review, and approve comprehensive validation documentation, including validation plans, user requirements, design and functional specifications, risk assessments, configuration specifications, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
• Apply a risk-based validation strategy consistent with GAMP 5 guidelines and site-specific procedures.
• Ensure full compliance of computerized systems with GMP, 21 CFR Part 11, EU Annex 11, data integrity, and electronic records/signature requirements.
• Collaborate extensively with Engineering, Automation, IT, Quality, Operations, Laboratories, and third-party equipment suppliers throughout system lifecycles.
• Evaluate system architecture, configuration, software functionality, interfaces, and data flows from a validation and compliance perspective.
• Support validation efforts for diverse systems such as DCS, PLC/SCADA, MES, process historians, laboratory, utility, manufacturing, and other GxP computer systems.
• Manage or assist in validation testing execution, handling deviations, and defect management.
• Conduct and document GxP system risk assessments to determine appropriate validation controls.
• Support commissioning and qualification activities where computerized systems interface with process equipment.
• Oversee validation deliverables from outside vendors and system integrators.
• Handle change controls, deviations, CAPAs, periodic reviews, and manage CSV lifecycle activities.
• Participate as a CSV subject matter expert in regulatory audits, internal inspections, and quality reviews.
• Provide mentorship and technical leadership to junior CSV/validation engineers.
• Champion continuous enhancement of CSV processes, documentation templates, and validation methodologies while maintaining regulatory compliance.

Experience & Qualifications

• Bachelor’s degree in Engineering, Computer Science, Automation, Science, Information Technology, or a related technical discipline.
• Typically 5 to 8+ years’ experience in Computer System Validation within pharmaceutical, biotech, or similarly regulated manufacturing environments.
• In-depth working knowledge of GAMP 5 and risk-based CSV methodologies.
• Solid understanding of EU GMP Annex 11, 21 CFR Part 11 regulations, and data integrity principles including ALCOA+.
• Proven track record in producing and executing CSV lifecycle documentation.
• Experience with GxP manufacturing or laboratory computerized systems validation.
• Strong grasp of validation lifecycle management, change control, deviation handling, and overall quality systems.
• Experience with automation, manufacturing, or laboratory systems is highly beneficial.
• Skilled at reviewing technical documentation and translating regulatory requirements into actionable validation strategies.
• Excellent stakeholder engagement and communication abilities, capable of collaborating with Quality, Engineering, Automation, IT, and Operations teams effectively.
• Self-motivated and capable of independently managing validation workstreams within complex projects.

Desirable Experience

• Familiarity with DeltaV or other Distributed Control Systems (DCS) platforms.
• Experience with PLC/SCADA systems.
• Knowledge of Manufacturing Execution Systems (MES).
• Exposure to OSIsoft PI or similar process historian systems.
• Experience with LIMS or laboratory systems.
• Working knowledge of Building Management Systems (BMS) and Environmental Monitoring Systems.
• Experience with serialization or packaging systems.
• Familiarity with ERP/SAP systems.
• Expertise in data integrity assessments.
• Automation or equipment qualification experience.
• Involvement in pharmaceutical capital projects, facility expansions, or technology transfer initiatives.

Additional Information

This position offers a chance to work on technically challenging pharmaceutical manufacturing and digital system projects within a stringent GMP-regulated framework. The Senior CSV Engineer will bear significant responsibility for validation strategies, execution, and compliance, collaborating closely with diverse engineering, automation, quality assurance, and manufacturing teams.