WuXi AppTec

  • Vice President Global Engineering

    Job Locations US
    Job ID
    2018-4156
  • Overview

    WuXi Biologics, a Hong Kong-listed company, is a leading global biologics services provider that offers comprehensive, integrated and highly customizable services. The company offers multinational pharmaceutical and biotechnological companies in the world end-to-end solutions empowering anyone and any company to discover, develop and manufacture biologics from concept to commercial manufacturing. Our services are designed to help our worldwide clients shorten the discovery and development time and lower the cost of biologics.  We are searching for a Vice President of Global Engineering to develop and manage strategy for facility development and continuous improvement.

    Responsibilities

    • Provide advice to SVP Biomanufacturing to develop the strategy for facility development, acquisition of existing facility, and continuous improvement/benchmarking/internal competition of existing facilities
    • Lead the efforts to develop the strategy and plan for the design, construction, C&Q, and life cycle management of facility and equipment including operation, maintenance, calibration, periodic validation, and upgrade and decommissioning of all GMP facilities and non-GMP facilities
    • Build and develop the Global Engineering team, Ireland Engineering team, Boston Engineering team and Singapore team, and Engineering team at sites outside China to support the development and operation of sites out of China
    • Lead the design, construction, C&Q, and life cycle management of facility and equipment including operation, maintenance, calibration, annual qualification/validation, upgrade and decommissioning of GMP facilities outside China
    • Lead the design, construction, and facility management of non-GMP facilities outside China
    • Oversee the design, construction, qualification and life cycle management of all facilities inside China
    • Coach, grow and train site team leaders through a matrix based mechanism involving site head of each facility
    • Direct the life cycle management of facility and equipment including operation, maintenance, calibration, periodic validation and minor upgrade of all GMP facilities through a matrix based system involving country/site engineering team and site head
    • Follow the regulatory guidelines and industry best practices
    • Align the practice, strategy and execution of entire engineering organization including global team, country team and site team through a matrix based system involving global team, country/site team and site head
    • Align the SOPs and guidance documents across all sites
    • Promote sharing of best practice, lesson learned and areas to improve identified by internal audit/review, client audit, FDA/EMA/CFDA inspection and industrial conferences
    • Promote competition among site teams to excel and benchmark industrial best practice in GMP compliance and engineering practice, including but not limited to design, construction, C&Q and life cycle management of facility and equipment
    • Build the knowledge space that can be shared across all global and site teams
    • Coach the PE team to develop design principles for GMP facilities
    • Coach the PE team to develop user manual for production team of a new facility and provide training of the user manual to the production team
    • Support engineering related audit/visit by clients and regulatory authorities
    • Coach global and site team for preparation, hosting and responding to audit and inspection
    • Host audit/inspection for engineering functions at audits/inspections outside China
    • Support audit/inspection for engineering functions at each site
    • Ensures that the design, construction, commissioning and qualification of new GMP facility comply with appropriate regulatory requirement and construction code
    • Ensures Management is well informed on progress of new GMP facilities
    • Other duties assigned by management

    Qualifications

    • Advanced degree and over 20 years of facility process and engineering management and facility development in pharmaceutical and biopharmaceutical facilities with at least 10 years in validation
    • Thorough knowledge of GMP requirements and experience in GMP environments working with Quality Systems
    • Project Management experience and methodologies
    • Knowledge and experience in EHS regulations and best practices
    • Ability to communicate technical details effectively in written and verbal English

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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