Job Title: Pharmaceutical Validation Specialist
A pharmaceutical validation specialist is required to support the current and future pipeline of CAPEX Projects including but not limited to Process and Packaging Equipment (OSD), Facilities and Utilities, and Computerized Systems and Automation Packages.
Responsibilities:
* * * * Prepare, review, and approve documentation for cGMP/Validation regarding equipment, facility, utility computerized systems automation packages manufacturing packaging processes.
* Provide input into project phases from design commissioning qualification preparation review approval of commissioning validation documentation document resolve assist closure of commissioning punch lists validation deviations initiated during commissioning qualification activities initiate manage change control records evaluate quality standard service providers c GMP vendor qualification documentation vendor management during commissioning qualification activities compile review approve c GMP documentation ensure up-to-date regulatory requirements all validated operations work management staff foster ethos culture c GMP quality awareness where c GMPs quality integral overall business ensure site-wide compliance data integrity management validation schedules timelines qualifications experience bachelor degree preferably engineering science technical field engineering degree preferred minimum 5 years related experience pharmaceutical manufacturing environment validation operations engineering combination thereof experience production or packaging processes systems process equipment facilities utilities technical writing gmp-related documentation risk assessments drafting risk-based approach test protocol creation relation validation activities