Validation Specialist

Validation Specialist

Empresa: Actalent. INTERESTED CANDIDATES: PLEASE SEND UPDATED RESUMES TO JAYSANDERS @ ACTALENTSERVICES.COM OR TEXT 513 . 620 . 1446 TO SCHEDULE A PHONE INTERVIEW Job Title: Validation Specialist Job Description The Validation Specialist supports the qualification and validation of laboratory and manufacturing equipment, systems, and processes within a state-of-the-art life sciences facility. This role begins with hands-on work in temperature mapping, periodic review, pipette validation, and biosealer validation, and progresses to the validation of bioreactors over time. The Validation Specialist works across quality laboratories, cleanrooms, and warehouse areas to ensure equipment and processes meet regulatory, quality, and internal compliance standards. This position is well-suited for recent graduates or early-career professionals in life sciences or engineering who are eager to grow their expertise in equipment validation and Good Manufacturing Practice (GMP) environments. Responsibilities - Perform temperature mapping, periodic reviews, pipette validation, and biosealer validation, gradually expanding responsibilities to include bioreactor validation. - Develop and execute equipment qualification protocols for manufacturing, processing, and filling equipment, as well as facilities and utilities that support these operations. - Support project-based validation activities, completing one project before moving to the next, such as validating multiple pieces of laboratory equipment for new cleanroom openings. - Analyze data generated by validation studies using statistical methods to determine process capabilities and assess performance. - Gather and organize relevant documentation, including executed batch records, certificates of analysis, equipment logs, equipment qualifications, and raw material certificates of analysis. - Investigate and resolve deviations or exceptions from predefined acceptance criteria identified during validation and qualification activitie