What are the responsibilities and job description for the Principal Validation Engineer position at Rentschler Biopharma?
Principal Validation Engineer position is a member of Validation Team (under Engineering Department umbrella) to demonstrate hands-on experience in developing and executing specifications, operating procedures, commissioning/qualification/validation (CQV) protocols and reports to perform Validation Life cycle of generation, execution, and reports for (DQ, FAT, SAT, IOPQ) of Manufacturing, QC, and Supply Chain process equipment (including Cleaning Validation) and maintain them in validated state.
This position is responsible for lifecycle qualification of our manufacturing facilities to support concurrent manufacturing operations.
Quallifications:
> Bachelor’s Degree or equivalent in Engineering (Chemical, Chemistry, Biology, Electrical, Mechanical, etc.), Life Sciences, or related scientific discipline.
> 7 years of hands-on, direct validation experiences in pharmaceutical / biotech industries, including minimum 3 years of managing projects (CAPEX/OPEX).
> Champion to adopt / apply principles of ASTM E2500 in CDMO manufacturing operations environment.
> Excellent technical writing ability for technical and compliance reports or submission.
> Experience in managing multiple projects and leading cross-functional project teams desired.
> Detailed knowledge of disposable technology preferred.