CSV Engineer II / III

Responsibilities:

Lead Data Process Flow Mapping activities to ensure all GMP systems are compliant with 21 CFR Part 11 regulations in preparation for BLA and PLI.
Ensure Computer System Operation and Administration SOPs are developed for all applicable GMP systems in preparation for PLI.
Lead and assist in Packaging and Label Validation activities.
Develop and execute validation protocols (IQ, OQ, PQ) for computerized systems to ensure compliance with regulatory requirements (e.g., FDA, GMP).
Perform risk assessments and impact analyses related to system changes or updates.
Collaborate with cross-functional teams to define user requirements and specifications for computer systems.
Write and review technical documentation, including validation plans, test scripts, and summary reports.
Conduct testing and document results to ensure systems meet functional and performance requirements.
Provide technical support and guidance to project teams throughout the system lifecycle.
Stay informed about industry trends and regulatory changes to ensure compliance.
Participate in audits and inspections, responding to findings and implementing corrective actions as needed.
Support continuous improvement initiatives related to CSV processes and procedures.
Other responsibilities as assigned related to computer system validation

Requirements:

Bachelor’s degree in Computer Science, Engineering, or a related field.
Prove experience (2+ years) in CSV within a regulated industry (pharmaceuticals, medical devices, etc.).
In-depth knowledge of FDA regulations (21 CFR Part 11, Part 210/211) and GMP guidelines.
Strong understanding of validation principles, methodologies, and best practices.
Experience with validation tools and documentation systems (e.g., Document Management Systems, LIMS).
Excellent analytical and problem-solving skills, with keen attention to detail.
Effective communication skills, both verbal and written, with the ability to convey technical information clearly.
Ability to work both independently and collaboratively in a team environment.
Relevant certifications (e.g., Certified Validation Professional) preferred.