Senior Quality Engineer, Computer System Validation (CSV)

About the role

The Sr Quality Engineer, Computer System Validation (CSV) is responsible for QA oversight of the validation and compliance of GxP-regulated computerized systems and any associated GMP equipment ensuring they are implemented, maintained, and retired in accordance with global regulatory requirements, industry standards, and internal procedures.

Primary Responsibilities

• Collaborate with IT and GxP system business owners to ensure internal CSV processes and procedures are aligned to GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9 (risk management), ICH Q10 (PQS), and FDA’s Computer Software Assurance (CSA) guidance.
• Serve as a team member to provide qualification expertise to CMC, Manufacturing Operations, Facilities, Quality Control and Engineering departments.
• Provide QA oversight for new system implementations, upgrades, integrations, cloud/SaaS solutions, and decommissioning activities.
• Experience validating GxP computerized systems, associated equipment (hardware) and digital platforms across laboratory, manufacturing, quality, ERP, or cloud-based environments.
• Approve validation deliverables (validation/assurance planning, testing strategy, traceability, UAT, periodic review, and retirement/archival plan, risk assessments, protocols, reports).
• Ensure validated systems remain in a controlled state through change management, periodic review, requalification, deviation management, and CAPA.
• Serve as QA reviewer/approver of deviations, CAPAs, change controls and effectiveness checks.
• Collaborate with customers and internal stakeholders to define validation strategies, risk-based approaches, and compliant delivery models aligned with GxP expectations.
• Review/approve comprehensive validation documentation, including validation plans, user and functional requirements, risk assessments, test scripts, and summary reports.
• Coordinate with vendors for maintenance, upgrades, and issue resolutions to minimize downtime.

Primary Skills and Knowledge

• Must have previous experience in Quality Assurance or Quality Engineering.
• Must have previous experience with GAMP5 system validation and validation of associated equipment.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Strong experience with regulated laboratory and/or manufacturing systems.
• Understanding of access control, security principles, and audit trail requirements in regulated environments.
• Strong documentation skills with experience authoring and maintaining validation and technical support documentation.
• Effective communication and collaboration skills, with the ability to interface between technical teams, vendors, and business stakeholders.
• Strong analytical and problem-solving skills with the ability to troubleshoot complex system issues in a timely manner.
• High attention to detail and commitment to data integrity.
• Prominent ability to lead medium-to-large projects, drive planning/controlling, and utilize tools like RCA, FMEA, and VSM.
• Experience supporting audits, inspections, supplier assessments, CAPA activities, data integrity initiatives, or compliance remediation programs is considered an advantage.

Education and Experience

• Minimum of 8+ years experience in the pharmaceutical or biotechnology industry.
• Minimum of 3+ years’ experience in GxP computerized system validation and associated equipment within the pharmaceutical, biotech, or medical device industry.
• Education: Bachelor’s degree(Scientific or Engineering discipline, or other technical disciplines); master's degree a plus.

Pay and Benefits

The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below:

$142,140 USD - $179,220 USD