Job Summary The Validation Engineer of WuXi Vaccines in Suzhou (company) shall be responsible for process validation work including aseptic process simulation, cleaning validation, shipping validation, and support other qualification work. Internally, this position is expected to work with all teams of the company and PEV teams of WuXi Biologics to ensure validation work is maintained in a compliant, timely and cost-effective way. Key Responsiblities · Validation management · Mainly responsible for aseptic process simulation, capable to define the strategy for APS and draft the related documents. The candidate should have the sense and the capability to do the trouble shooting and problem-solving work. · It is better to have the cleaning validation and shipping validation experience, have the basic sense about the cleaning strategy. It will be a plus if you have the shopfloor working experience. · Team work · The candidate should have strong ownership. · Cross functional work and conflict management. · Compliance · Proactive tracking of regulations and the ability to identify gaps in correspondence · Responding positively to an audit can be a good way to present your area · Business development · Support the BD team and work in synergy with other teams of the company to win vaccine CDMO projects for assigned site and other sites of the company · Lead the introduction and host the due diligence and audit of qualification · Supporting work · Support other qualification work · Support internal and external audit when necessary · Respect and follow EHS and ESG rules · Other work assigned by line manager Qualification · Master in a science or engineering discipline Fluent in English and Chinese Experience · More than 4 years’ working experience in a GMP manufacturing environment supporting or leading validation responsibilities for clinical and commercial products · Experience with DP aseptic production or cell banking experience · Experience of green or brown field project · Experience at both contract giver and receiver is a plus · Experience in biopharma or big molecule industry is a plus Experience of regulatory and customer audits is a plus Skills · Effective communication and good interpersonal skills · Demonstrated leadership to adapt to daily challenges while maintaining positive and productive attitude and fostering this attitude among subordinates · Operation skills of validation instruments · Ability to support key activities and priorities within a cross-functional team · Ability to perform multiple tasks effectively in a busy environment · Demonstrated skills for problem solving and investigation · Knowledge of FDA, EU, WHO, NMPA and PIC/S GMP requirements Knowledge of PDA and ISPE is a plus
