/ EN


QA Validation Engineering Specialist - Wuhan


 · Conforming with Good Practice (GxP) quality guidelines and regulations for the Biopharmaceutical industry including Documentation (GDP), Manufacturing (GMP) and Automated Manufacturing (GAMP)

· Managing/resourcing the installation and validation of new moulding tools and automated assembly lines though all stages, from Factory/Site Acceptance Testing (FAT/SAT) to Installation/Operational/Performance Qualification (IQ/OQ/PQ)

· Develop Validation Strategy, risk assessment and procedures, MVP, URS, FAT, SAT, FMEA, IQ, OQ & PQ protocols
-Validation of Process / Equipment / Facility / Cleaning / Test Method (TMV) / Plant Automation / Computerized systems (Part 11) / Documentation Management Systems

· Generating Validation documentation (Protocols/Checklists/Reports) for validation activities, and creation/updating of ancillary documentation required to release tool/line for GMP production

Job Responsibilities

· Develop moderate to highly complex protocols for validation projects using a risk based

· Represent validation during tech transfer activities as required.

Job Qualifications (Education, Certifications, Experience)

· BS or MS in Engineering or related discipline

· Excellent English reading and verbal ability

· Experience in multiple GMP validation disciplines (process equipment, utility, laboratory, automation, computer systems, sterilization, sterile filling/isolator) with advanced technical knowledge

· Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc) guidelines, international regulatory requirements and standards and other in