Senior Quality Engineer, Computer System Validation (CSV)

About the role

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

Responsibilities

• Collaborate with IT and GxP system business owners to ensure internal CSV processes and procedures align with 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.
• Approve validation deliverables (validation/assurance planning, testing strategy, traceability, UAT, periodic review, 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.

Requirements

• Minimum of 8+ years of experience in the pharmaceutical or biotechnology industry.
• 3+ years of experience in GxP computerized system validation and associated equipment within the pharmaceutical, biotech, or medical device industry.
• Experience validating GxP computerized systems, associated equipment (hardware), and digital platforms across laboratory, manufacturing, quality, ERP, or cloud-based environments.
• Bachelor’s degree in a Scientific or Engineering discipline, or other technical field; master's degree a plus.

Skills

• Previous experience in Quality Assurance or Quality Engineering.
• Experience with GAMP5 system validation and validation of associated equipment.
• Sound, systematic problem-solving methodologies for 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.
• Ability to manage GxP system lifecycle activities including change control, deviations, CAPAs, and periodic reviews.
• 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.
• Proven 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.

Pay

Salary Range: $142,140 - $179,220 USD

Benefits

• Transformational Innovation: Forward-looking culture that embraces challenges with curiosity, continuously seeks improvement, and pushes the limits of science and technology.
• Unwavering Integrity: High ethical standards and responsible leadership at every level, valuing trust from patients, employees, and the community.
• Compassionate Excellence: Culture where fun and excellence coexist, emphasizing enjoyment of work and care for each other alongside exceptional outcomes.
• Inclusive Collaboration: Teamwork that values diverse perspectives, ensuring everyone feels valued, respected, and encouraged to contribute ideas.