Quick overview
Job description
- Strong MES background, specifically 5–7 years of MES experience.
- Technical/project leadership capability.
- Potentially temp-to-hire.
- Could work remotely with periodic onsite presence, ideally 2–3 days every other week.
- Lead end-to-end MES projects, ensuring delivery of scope, schedule, budget, and quality objectives.
- Manage cross-functional teams including Manufacturing, Quality, Validation, Automation, IT, and external vendors.
- Drive project planning, risk management, stakeholder communication, and governance activities.
- Provide technical leadership and oversight for MES implementation, integration, and enhancement initiatives.
- Coordinate requirements, solution design, testing, deployment, and hypercare activities.
- Support digital manufacturing transformation programs and continuous improvement initiatives.
- Ensure compliance with GMP, GxP, Data Integrity, and validation requirements.
- Manage project reporting, status updates, issue resolution, and executive stakeholder communications.
- 5–7 years of hands-on MES experience in pharmaceutical, biotechnology, or life sciences manufacturing environments.
- Proven experience leading MES implementation or upgrade projects.
- Strong understanding of MES platforms such as POMS, PAS-X, PharmaSuite, Opcenter, or Syncade.
- Demonstrated technical and project leadership capabilities.
- Experience working with Electronic Batch Records (EBR), manufacturing workflows, and shop-floor systems.
- Knowledge of MES integrations with ERP, LIMS, Automation, SCADA, and related manufacturing systems.
- Strong stakeholder management, communication, and problem-solving skills.
- Experience working within regulated environments and managing system validation activities.
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