Associate Director, MES Boudry Site Lead

vor 1 Woche

Boudry District, Schweiz Bristol-Myers Squibb Vollzeit
Transforming Patients' Lives through Science

Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director, Manufacturing Execution Systems (MES) Lead for our Boudry site to lead our MES program and ensure quality and efficiency of MES projects and deployment.

Key Responsibilities:
  • Lead a matrixed organization composed of site direct reports, indirect reports, and contractors to deliver effective, innovative, and stable solutions that meet the needs of the facility.
  • Partner with Mfg. Operations colleagues, Enterprise IT team, Enterprise Business team, and local system Digital Capability Managers to deliver the requirements for the Boudry facility.
  • Syncade Recipe requirements, design, and development integration needs with SAP, LIMS, Maximo, and other systems.
  • Integration with Manufacturing Benchtop Equipment delivery of Batch Reporting (InfoBatch) & Quality Review Manager (Syncade QRM) requirements.
  • Help set the MES priorities for the Boudry Site and coordinate the delivery of these priorities.
  • Lead the technical teams to test the deliverables and drive execution of system testing at the site level.
  • Support the business by providing guidance on Qualification and Validation processes.
  • Coordinating enterprise MES deliverables with site and ensuring the site requirements are being met by the enterprise BMS MES library.
  • Collaborate with other network MES leads to proactively identify issues, drive resolutions, and define product roadmap.
  • Work with enterprise MES team and SMEs to develop MES standards, philosophy, design approach, and SOPs for Boudry Facility.
  • Work with the enterprise MES team and the business to develop Business continuity plan for Boudry Site MES application.
  • Drive and support the resolution of critical MES issues.
  • Provide IT leadership to site inspection readiness from an MES perspective.
  • Couch and mentor MES engineers on Boudry requirements and deliverables.
  • Manage contractual vendors.
  • Lead and implement the design of 'agile' MES for the new launch facility.
Requirements:
  • Bachelor's degree in Engineering, IT, Science field, or equivalent experience.
  • Minimum 7 years' relevant industry experience. Prior Pharma or regulated industry experience is highly valued.
  • Demonstrated expertise in MES technologies, preferably Syncade, with knowledge of historian and reporting technologies.
  • Experience with Emerson, OSI PI, Crystal Reports, SQL Reports, Visual basic expertise would be preferable.
  • MS Windows Server and MS SQL server also a plus.
  • Working knowledge of SDLC, GAMP, CSV, and 21 CFR Part 11 regulations is required.
  • System integration experience between Syncade and Enterprise system (SAP, LIMS, Maximo, Veeva Doc, etc) and Manufacturing equipment.
  • Deep understanding or rich knowledge of Syncade architecture and management in the industry.
  • Strong verbal and written communication and collaboration skills.
  • Demonstrated ability to partner and influence stakeholders to achieve shared outcome.
  • Demonstrated ability of coaching junior team members on technical perspective.
  • Ability to work in a diverse work environment, manage multiple priorities, and be self-directed.

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