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Prin Spec MES

Company: Bayer
Location: Berkeley
Posted on: November 18, 2022

Job Description:

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Prin Spec MES

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Prin Spec MES, are to:

  • Technical subject matters for all MBR design/functionalities;
  • Technical user representative for GMP systems (MES, SAP, DCS, Discoverant) and projects with MES/MBR impact;
  • CA stakeholder for MES/MBR impact;
  • DR/CAPA technical evaluation for MES/MBR;
  • Document author for MBR design, revisions, maintenance and training;
  • Approval of content for User guides, troubleshooting guide, and any document referencing MES/MBR process;
  • Lead coordination/preparation for internal and external audits for electronic batch record reviews;
  • Create / revise MBRs and maintain business process changes to documentation/standard operating procedures relevant to governing creation and revision of MBR's;
  • Provide leadership and coaching to MES specialists in regards to strategy, coordination, prioritization of document revisions, and standardization of business process execution;
  • Create MES system and MBR specific training material and maintain business process changes/standard operating procedures relevant to MES and MBR training;
  • Establish and maintain contracting relationship and contingent workforce that can be called upon to create/revise/deploy MBR's;
  • Create efficiency with turnaround time for MBR creation/revision and approval cycle;
  • Provide guidance/training to MES Specialists in generating improvement strategies and coordinating resolution to MBR test plan process as opportunities/issues are identified;
  • Effectively manage MBR revision area performance issues/challenges by implementing process improvements/corrective actions;
  • Review/disposition MBR test results and develops strategies for corrective actions by planning and facilitating MES Specialist team activities;
  • Ensure training system LMS is properly updated for MES related items and verify standardization of execution/expectation within MES Specialist team;
  • Provide training to MES Specialists regarding quality of work expectations/standardization;
  • Interact / communicate with impacted departments and facilitate resolution of complex MES/MBR changes.

    WHO YOU ARE

    Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks and incumbent who possesses the following:

    Required Qualifications:

    • Bachelor's Degree or an equivalent combination of education and experience;
    • Extensive MES system expertise and ability to design MBR's;
    • Good API and SFF Manufacturing process knowledge;
    • Very good knowledge of interaction with external systems (DCS, SAP, ECS, Discoverant);
    • Extensive knowledge of MES system standards for Berkeley site;
    • Extensive ability/knowledge to build test data;
    • Extensive knowledge of review by exception;
    • Extensive experience with testing procedure;
    • Extensive knowledge of creating training material;
    • Very good ability to prioritize competing requirements/projects;
    • Good ability to negotiate win-win scenarios with cross functiona stakeholders;
    • Very good communication and training skills;
    • Very good knowledge of change control process;
    • Very good influencing skills to motivate and steer team to deliver expected results.

      Preferred Qualifications:

      • Master's of Science YOUR APPLICATION
        Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
        To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

        Bayer is an Equal Opportunity Employer/Disabled/Veterans

        Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
        IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer expects its employees to be fully vaccinated against COVID-19. Bayer active employees are also expected to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status to Occupational Medicine. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, Bayer employees are also required to comply with state, local and customer requirements. Location: United States : California : Berkeley Division: Pharmaceuticals Reference Code: 779999 Contact Us Email: hrop_usa@bayer.com

        Job Segment: CAPA, Public Health, SAP, ERP, Healthcare, Management, Technology

Keywords: Bayer, Berkeley , Prin Spec MES, Other , Berkeley, California

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