CSV Engineer (Raleigh-Durham-Chapel Hill Area)

We are seeking an experienced and highly skilled Senior Computer Systems Validation (CSV) Engineer to join our Life Sciences team. This role is responsible for leading and executing validation activities for GxP-regulated computerized systems in compliance with applicable regulatory requirements and industry best practices. The Senior CSV Engineer serves as a technical leader and subject matter expert for validation strategy, risk-based compliance, and system lifecycle management across manufacturing, laboratory, quality, and enterprise systems.

The ideal candidate will possess extensive experience in regulated pharmaceutical, biotech, and/or medical device environments and demonstrate expertise in validation planning, execution, deviation management, data integrity, and cross-functional project leadership. This position requires strong technical knowledge, client-facing communication skills, and the ability to mentor junior engineers while supporting complex validation and automation initiatives.

DUTIES AND RESPONSIBILITIES:

 Lead and execute the full lifecycle validation of GxP computerized systems, including planning, requirements gathering, testing, implementation, maintenance, and retirement activities.

 Develop and review validation lifecycle documentation for GMP manufacturing, laboratory, automation, and enterprise systems, including:

• Validation Plans (VP)
• User Requirements Specifications (URS)
• Functional Specifications (FS)
• Design Specifications (DS)
• Configuration Specifications
• Risk Assessments
• Traceability Matrices
• IQ/OQ/PQ protocols
• FAT/SAT documentation
• Validation Summary Reports
• Standard Operating Procedures (SOPs)
• Change Controls and Deviations

 Provide technical leadership and strategic guidance for risk-based validation approaches aligned with GAMP 5 principles and regulatory expectations.

 Lead client-facing validation activities and collaborate with Quality Assurance, Engineering, IT, Manufacturing, Automation, and Regulatory Affairs teams.

 Support and oversee commissioning and qualification (C&Q) activities for automated and computerized systems.

 Review and approve change controls, deviations, CAPAs, and system modifications impacting validated systems.

 Perform and support data integrity assessments and ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles, and global regulatory requirements.

 Coordinate and manage validation deliverables, project timelines, and cross-functional resources to ensure successful project execution.

 Support internal and external audits and regulatory inspections by providing validation documentation and compliance expertise.

 Mentor and provide technical guidance to junior validation engineers and project team members.

 Participate in continuous improvement initiatives related to validation processes, documentation standards, and compliance programs.

•  Assist in development and standardization of validation templates, procedures, and best practices across projects and business units.

REQUIRED SKILLS/ABILITIES:

 Extensive knowledge of GAMP 5, risk-based validation methodologies, and computerized system lifecycle management.

 Strong understanding of:

• FDA 21 CFR Part 11
• EU Annex 11
• Data Integrity guidance
• cGMP regulations
• CSV regulatory expectations within pharmaceutical and biotech industries.

 Proven experience validating:

• Manufacturing Execution Systems (MES)
• SCADA/HMI systems
• PLC/Automation systems
• Laboratory systems (LIMS, CDS)
• Enterprise applications and cloud-based systems.

 Advanced experience executing and reviewing commissioning, qualification, and validation testing documentation.

 Demonstrated expertise managing deviations, discrepancies, investigations, and change control processes.

 Strong technical writing, organizational, and documentation skills.

 Excellent project management and client communication abilities.

 Ability to lead multiple projects and priorities in fast-paced regulated environments.

 Experience leading cross-functional teams and mentoring junior staff.

 Familiarity with software development lifecycle (SDLC) methodologies and computerized system infrastructure is preferred.

 Strong analytical, troubleshooting, and problem-solving skills.

EDUCATION AND EXPERIENCE:

• Bachelor’s or Master’s Degree in Engineering, Computer Science, Life Sciences, Information Technology, or a related technical discipline required.
• Minimum of 5+ years of Computer Systems Validation (CSV) experience within pharmaceutical, biotechnology, medical device, or other regulated industries.
• Demonstrated experience leading complex validation projects and interfacing directly with clients, quality organizations, and regulatory agencies.
• Experience with automation systems, manufacturing systems, and/or laboratory systems validation strongly preferred.
• Equivalent combinations of education, technical training, and relevant industry experience may also be considered

PHYSICAL REQUIREMENTS:

The physical requirements listed below represent the minimum standards that an employee must meet to perform the essential functions of this role successfully. Reasonable accommodations can be made to enable individuals with disabilities to perform these functions.

• Regularly required to sit, use hands, and communicate verbally.
• Occasionally required to stand, walk, and reach with hands and arms.
• Must occasionally lift and/or move up to 50 pounds.