Manager, MES

The primary function is to lead the team of Business Analysts to develop, validate, implement, and troubleshoot the setup of MES (POMs) recipes for the site. Ensure the site follows Global IT standards in MES while overseeing integration with other programs such as Maximo, SAP, Automation, etc.

Responsibilities:
- Establish and advance a high performing team of SMEs (recruit, train, coach, develop); communicate goals, expectations, role responsibilities, and feedback.
- Own POMS design for site operations; lead recipe authors to deliver and support POMS SLA (troubleshoot complex issues and conduct product/process investigations).
- Liaison between plant stakeholders and the global MES team; lead requirements gathering and develop URS (user requirement specifications).
- Manage recipe authoring for first-in-class templates; lead validation approach during start-up and re-validation/verification during maintenance (e.g., NPI change).
- Lead POMS FMEA creation and revision with the global team.
- Develop critical SOPs (e.g., BCP, periodic system review, incident management).
- Lead continuous improvement projects related to MES.
- Support data integrity projects and compliance, regulatory and internal audits.
- Support development/configuration of SAP solutions for the manufacturing recipe process using Process Control Records and specification documents to integrate accurately with MES.
- Ensure EHS requirements and compliance; consider EHS in design and change.

Qualifications:
- Bachelor’s degree in Business Administration, Engineering, or Computer/Information Systems (Master’s preferred).
- 8+ years manufacturing/quality experience in a pharmaceutical manufacturing plant.
- 3+ years hands-on MES experience.
- Strong Computer Systems Validation skills; good project management; excellent verbal/written communication.
- Strong interpersonal/leadership skills; knowledge of GMP and safety regulations.