Johnson & Johnson Careers

Validation SME

Shanghai, China
Validation


Job Description

Requisition ID: 1805690883W

In alignment with the Regional Validation Leader the SME Validation to provide technical  support to the execution of Process , Cleaning& Sanitization  validation of  Cosmetic and OTC Class 2 Products across the regional Consumer organization to ensure compliant and efficient performance consistent with established J&J guideline and policies.  
For the specific technological area of competence, he/she is the regional Subject matter expert (SME) for Process and Cleaning Validations: developing, finalizing, and implementing regional validation protocols and reports according to specific instructions, and supporting validation and qualification policies, procedures, and programs. 
The role is also responsible for execution of validations for process, filling & packaging validation and for  Band-aid manufacturing process at Shanghai campus. 

Additional responsibilities include:
· Be well-versed in the principles and approaches of process validation in the regional Consumer organization
· Complete and execute validation protocols and reports in a timely and compliant manner to meet project and business objectives
· Support the development and continuous optimization of  Consumer Products Validation program improving approaches to validation execution based upon risk management approach.
· Collaborate with the Global Technology leader for Cosmetics and OTC2 to define standards, harmonized procedures, and streamlined templates.
· Support the development and continuous optimization of JJFCC Consumer Products Validations program, improving compliance and efficiency of validation execution based on a risk management approach.
· Deploy the globally defined standards within the region, aligning with the Global Technology leaders.
· Serve as the regional validation Subject Matter Expert and Point of Contact (SME-POC) for the team and provide validation oversight and guidance.  Responsible for communicating and elevating critical business-related issues, as well as opportunities, to senior management.
· Serve as SME during J&J and Health Authorities inspections/audits.
· Coordinate with all sites in the region to collect performance measures and to release functional report as per plan
· Participate in establishing key performance metrics to evaluate validation efficiency.
· Establish and ensures the rigor of testing during all qualification/validation activities to be consistent with International and local applicable Authorities as well as Company requirements.
· Perform work in compliance with GMP and compliance standards for activities where applicable.
· Contribute to the achievement of company and departmental objectives, while respecting corporate procedures governing the employment relationship and policies for ethical conduct.
· Contribute to the improvement of the quality of the work environment by promoting and encouraging actions consistent with the Corporate Credo.
· Cooperate actively with production Make departments, R&D, SMP, Engineering, GP,  QA and QC planning to ensure completion of validation activities in the required mode and time.
· Support investigation of validation problems and in cooperation with the Quality organization in wider investigations
· Carry out work while respecting the procedures and safety rules for him/herself and for the organization.
· Report to the Global Technology leader any situation that could endanger the health and safety of workers and/or the environment.
· Contribute to the containment of departmental costs, while contributing to the improvement and optimization of business processes.
· Define and implement process excellence (PE) and cost improvement (CIP) projects.

Qualifications
1 Required Education/Training and/or Experience: 
Bachelor’s degree in physical sciences, Engineering, or appropriate related equivalent field
8-12 years’ experience in related field.  Well versed with GMP standard.  Cosmetic and OTC product knowledge is strongly preferred.
3+ years’ experience performing process, cleaning, or other validation in a regulated environment; strong knowledge of principles in validation and current industry approaches
3+ yr. of Project Management experience strongly preferred
Experience in Health Authorities inspection management preferred.
Experience with filling / packaging validation preferred.

2 Required Knowledge ,Skills and Abilities:  
· Strong collaboration, communication, and presentation skills required.  Fluency in written and oral communication in English preferred. 
· knowledge and application of FDA, ISO, applicable regulatory requirements and latest guidance in the development, validation, and manufacture of cosmetic and OTC products would be required
· Ability to collaborate with and influence manufacturing site leadership teams regarding prioritization and resourcing required.
· Knowledge and application of cosmetic/OTC manufacturing and formulation technologies for liquid and solid dose manufacturing and product development is desirable
· Experience in performing process, cleaning or other validation activities in a regulated environment desirable
· Ability to provide technical leadership in problem-solving and decision-making; to collaborate with and influence business partner leaders with a focus on data, science, and technology required.
· Ability to constructively challenge cross-functional project teams and business partners to achieve project goals and global make strategic plans required.
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Primary Location
China-Shanghai-Shanghai-3285 Dongchuan Road
Organization
Johnson & Johnson (China) Ltd. (7047)
Job Function
Validation
Requisition ID
1805690883W