• Senior Manager, Manufacturing Systems

    BeOne Medicines (Hopewell, NJ)


    General Description:

    Senior Manager Manufacturing system is a key member of the Hopewell Site IT Team. They will be the IT Partner helping with installation, validation and maintenance of various GMP systems such as MES, DCS, EMS.

    Essential Functions of the job:

    + Expertise with MES, E-Logbooks, DCS, SCADA, BMS, EMS and asset management system (Maximo) function and implementation.

    + Experience with one of the following platforms: Rockwell DCS, DeltaV, Allen Bradley / Siemens PLC, Aveva PI historian, Instrumentation and control panel hardware as required

    + Good understanding of ISA 95, Industry 4.0 concepts and technology.

    + Periodic system reviews, audit support, and user management in support of GMP

    + Solid strategic thinking, project management, team leadership and people management

    + Proven expertise in both Microsoft Office Suite and related systems including MES, ERP, PLM, and asset management system.

    + Excellent problem-solving, organizational, communication, analytical and critical thinking skills including high discretion/judgment in decision making.

    Required Qualifications:

    + Bachelor’s degree in engineering, computer science or a technical degree in a related field.

    + 7+ years demonstrated track record of implementing and administering Manufacturing systems within a variety of industries.

    + Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV).

    + Demonstrated track record in Engineering/IT/Pharma supporting manufacturing digital transformation, Pharma 4.0.

    + Experience in the FDA regulated manufacturing of biological drug products.

    + Demonstrated track record in People and Project management.

    Computer Skills:

    + Windows Server management, Active Directory

    + VMWare, AWS

    + MS SQL Servers, Maximo, Veeam

    Supervisory Responsibilities:

    + Contract resources

     

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.