We are seeking an experienced MES PAS-X Center of Excellence (CoE) Lead to drive best practices, standardization, and continuous improvement initiatives for our client Manufacturing Execution System (MES) using PAS-X. This role will serve as a technical and strategic leader, ensuring seamless MES deployment and optimization across our manufacturing sites. The ideal candidate will bring deep expertise in PAS-X, digital transformation, and cross-functional collaboration to enhance operational efficiency.
Key Responsibilities:
- Lead the MES PAS-X Center of Excellence, setting strategic direction and driving standardization across multiple manufacturing sites.
- Serve as the primary subject matter expert (SME) for PAS-X MES, ensuring best practices in system architecture, configuration, and deployment.
- Collaborate with IT, Engineering, Manufacturing, and Quality teams to optimize MES functionalities and improve system performance.
- Define and implement governance frameworks, templates, and standard operating procedures for MES usage and compliance.
- Oversee system upgrades, validation, and change management in alignment with regulatory requirements (e.g., FDA, GMP, GxP).
- Drive continuous improvement initiatives to enhance system efficiency, reduce downtime, and improve overall manufacturing productivity.
- Manage and mentor a team of MES engineers and specialists, providing technical guidance and professional development.
- Engage with external vendors, partners, and stakeholders to align MES strategies with industry best practices and emerging technologies.
- Support digital transformation initiatives by integrating MES with ERP, LIMS, and automation systems.
- Ensure compliance with data integrity, cybersecurity, and industry regulations.
Qualifications & Experience:
- Bachelor’s or Master’s degree in Engineering, Computer Science, Information Systems, or a related field.
- 7+ years of experience in MES implementation and management, with at least 5 years of hands-on expertise in PAS-X.
- Strong knowledge of pharmaceutical, biotech, or life sciences manufacturing processes and regulatory environments.
- Experience in leading cross-functional teams and driving MES standardization across multiple sites.
- Familiarity with SQL, scripting, system integration (SAP, LIMS, SCADA, Automation, etc.) is highly desirable.
- Proven ability to lead MES projects, validation, and change control processes in a GMP-regulated environment.
- Excellent communication, problem-solving, and leadership skills with the ability to influence stakeholders at all levels.
- Willingness to travel occasionally to different manufacturing sites as needed.