Job description
- 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.).
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Frequently asked questions
Q: What skills or qualities help someone succeed as a System Validation Engineer?
A: To succeed as a System Validation Engineer, key technical skills include proficiency in programming languages such as Python, C++, or Java, as well as experience with testing frameworks, automation tools, and version control systems like Git. Additionally, strong analytical and problem-solving skills, attention to detail, and the ability to communicate complex technical information effectively are essential soft skills for this role. By combining these technical and soft skills, a System Validation Engineer can effectively design, develop, and execute validation plans, ensuring the reliability and quality of complex systems, which in turn supports career growth and effectiveness in the role.
Q: What is the career path for a System Validation Engineer?
A: A System Validation Engineer's typical career progression involves starting as a Validation Engineer or Test Engineer, where they develop and execute test plans to ensure system compliance with regulatory requirements. As they gain experience, they can move into mid-level roles such as Senior Validation Engineer or Lead Validation Engineer, where they oversee validation teams and develop more complex test strategies. Ultimately, senior System Validation Engineers can transition into leadership positions like Validation Manager or Director of Quality Assurance, where they drive organizational quality initiatives and develop strategic plans for regulatory compliance.
