Senior Validation Specialist/Manager

Role Summary/Purpose: Responsible for building up an******** GE lifesciences validation services in China for China market to support Chinaoverall bioprocessing business growth. This role is the expert in singleuse val******** bioprocessing systems an******** val******** an********the leader to buil******** an******** GE validation services to offer GEas a total solution provider.
Essential Responsibilitie********
- Work closely with commercial team an******** en********, tounderstan******** identify the important areas of validationrequire******** serve the market needs.

- Work closely with global regulatory an******** experts, to translatethe knowledge an******** into China market, as well as feedback Chinaneeds for central prioritization.

- Proactively engage with biopharmaceutical customers to offer GEvalidation services an********, to help their clinical pathways.

- Shortlist an******** the validation services (extractable********,filtration val******** etc.) to be set up base******** the marketnee******** better support GE LS growth. Identify the right testingsuppliers (both internal an********) an******** all through to achievethe best result for both GE an********.

- Set up the validation testing protocols, project management for theactual testing processes, through to deliver the approve******** tobiopharm. Customers.

- Initial responsible for developing an******** extractable********documentation an********; Write an******** protocols, proce********reports an******** documentation as necessary to support the customer;Identify critical process parameters an******** experimental analyses;Utilize scientific principles an******** to independently executean******** experiments in the process of validation; Work with internalassociates an******** experts to manage the challenges includingunexpecte******** ******** technical hur******** trouble shootingan******** within test project; Cooperate an******** with projectcoordinator to ensure project progress.

- Deliver validation trainings to customers an******** during key eventsan********.

- Drive for opportunities to interact with regulatory agency (CFDA)an********. Customers to understan******** latest guideline******** forbioprocessing an********-use regulations.

- Establish the validation services capability for GE life sciences inChina. Shape GE as the leading validation services provider in thebiopharm. Market.

- Shortlist an******** the validation services (extractable********,filtration val******** etc.) to be set up base******** the marketnee******** better support GE LS growth.

- Provide expert technical support in validation to meet objectives of******** output an******** in ******** trouble shoot********standardising an******** new an******** project.

- Assure that all validation test procedures are in line with currenttechnology, corporate an******** regulations.

- Responsible for developing an******** extractable documentationan********; Write an******** protocols, proce******** reports an********documentation as necessary to support the customer; Identify criticalprocess parameters an******** experimental analyses; Utilize scientificprinciples an******** to independently execute an******** experiments inthe process of validation; Work with internal associates an********experts to manage the challenges including unexpecte******** ********technical hur******** trouble shooting an******** within test project;Cooperate an******** with project coordinator to ensure projectprogress.
Qualification********
- Problem solving ability an******** oral an******** Englishcommunications skills

- Minimum Master Degree in Sc******** Engineering or a relevant Qualitydiscipline.

- Minimum 5 years experience in a similar role.

Key Competencie********

- Ability to Lea******** team

- Customer service

- Honesty an********

- Planning an********.

- Drive for results

- Creative an******** th********

- Focus on quality

- Attention to detail
Additional Eligibility Qualification********
Desire****************
- Proven an******** previous experience in validation/service********development for biopharmaceutical applications;
- Extensive polymer chemistry an**************** knowledge an********for medical device or pharmaceutical/biopharmaceutical.
- Knowledge of biopharmaceutical process******** such as upstream,f******** UF/DF, Chromatography, formulat******** single-use technology,an******** relevant validation.
- Knowledge of cGMP’s an******** worldwide regulatory requirements.BPSA, PDA, BPOG, GMP, USP, FDA, ICH, EP, JP, ISO, REACH, ISPE an********Standard.


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