Computer System Validation Engineer
Summary:
- The Computer Systems Validation (CSV) works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.
- This role is an individual contributor.
- The CSV will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle.
- The CSV has primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with the relevant Client procedures and regulations.
- Author, review and / or approve applicable CSV documentation.
- Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures.
- Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
- Other related duties as assigned.
- Ability to effectively communicate with both technical and non-technical team members.
- Strong interpersonal skills, especially regarding teamwork, 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.
- Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).
- Understanding of Computer System Validation (CSV).
- Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement) 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.).
