What are the responsibilities and job description for the Computer System Validation Engineer position at Katalyst HealthCares & Life Sciences?
Responsibilities
- Develop Project Plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP).
- Finished Goods Manufacturing (FGM) Manufacturing, and IT Computerized Systems.
- Assist in the generation and development of documents, processes, and procedures of the Computer Systems Validation (CSV) program.
- Generate and review Manufacturing and IT Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
- Ensure that the Computer System Validation on the project is conducted in a consistently high standard, within budget, and that objectives are met on time suiting the company's vision and objectives.
- Collaborate and align with other Diosynth Biotechnologies sites.
- Coordinate with Computer System vendors as needed.
- Opportunities to make periodic International and Domestic travel Requirements.
- Bachelor's degree in chemical engineering, Computer Engineering, Computer Science, Biological Science, or technical equivalent.
- 5 years' direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA regulations.
- Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including ASTM2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11.
- Working knowledge of Kneat validation software is a plus.
- Excellent oral and written communications skills and fluency in English.
- Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
- Knowledge with Drug Substance Manufacturing (DSM), Drug Product (DP), and/or Finished Goods Manufacturing (FGM) would be beneficial.