Computer System Validation Engineer

Duties And Responsibilities

• Author, review and/or approve applicable CSV documentation
• Absorb and document test failures during test execution
• Ensure testing aligns with internal procedures
• Collaborate with Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
• Perform other related duties as assigned

REQUIRED COMPETENCIES

• Effective communication with both technical and non-technical team members
• Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing
• Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow)
• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva)
• Strong technical and problem-solving skills and the ability to work independently
• Demonstrated success working in a high-performing, business results-driven environment
• Understanding of computer system validation
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing
• Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow)
• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva)
• Strong technical and problem-solving skills and the ability to work independently
• Demonstrated success working in a high-performing, business results-driven environment
• Understanding of computer system validation (CSV)

Education And Experience

• Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience
• 4+ years of direct experience with CSV activities
• Strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
• Strong knowledge on Manufacturing Execution System (MES) validation
• Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
• Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)