- Manati, United States
Provide validation and documentation support for Manufacturing Execution Systems (MES) and Electronic Batch Records (eBRs) in a regulated pharmaceutical manufacturing environment.
Responsibilities
- Develop, review, update, execute, and maintain computerized system validation documentation in accordance with GMP regulations and data integrity principles.
- Support validation lifecycle documentation including URS, Functional Specifications, Design Specifications, Configuration Specifications, Risk Assessments, and Traceability Matrices.
- Develop and execute IQ/OQ testing protocols and document validation results.
- Coordinate activities with cross‑functional technical and business teams.
- Prepare and review validation reports and summary reports.
Requirements
- Bachelor’s degree in engineering, Computer Science, Information Technology, Life Sciences, Chemistry, or a related technical discipline
- Nice to have: Syncade Enterprise MES (EMES)
- Nice to have: Electronic batch record implementation
- Nice to have: CSV risk assessments
- Nice to have: Data Integrity Assessments