MES Program Manager

Position: MES Program Manager – Pharmaceutical Manufacturing

Location: Indianapolis IN 46225 onsite

Duration: 12-36 months

I am looking for a seasoned MES Program Manager to lead a critical, multi-site Manufacturing Execution System (MES) implementation across our global pharmaceutical manufacturing network.

This role will drive 18 strategic workstreams supporting our digital manufacturing transformation, with a focus on operational efficiency, regulatory compliance, and global standardization.

The ideal candidate brings deep experience in pharmaceutical manufacturing, strong program leadership, and a proven track record of delivering validated MES systems in GMP-regulated environments.

Overview of Responsibilities:

• Lead the global MES Program from design through deployment, overseeing 18 interconnected workstreams to ensure successful delivery across sites.
• Collaborate closely with stakeholders from Manufacturing, IT, OT, QA, Validation, Engineering, and Regulatory Affairs.
• Manage vendor selection, system configuration, integration with ERP (e.g., SAP), SCADA, historians, and lab systems (e.g., LIMS).
• Ensure adherence to GMP, GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles throughout the program.
• Oversee Computer System Validation (CSV) activities, documentation, and audit readiness.
• Align local plant implementations with the global MES template, supporting standardization and process harmonization.
• Develop and track KPIs related to system performance, batch record accuracy, and operational improvements.
• Lead change management and training initiatives to ensure system adoption and cultural alignment.
• Report program status, risks, and mitigation plans to executive sponsors and the global PMO.

QUALIFICATIONS

• Bachelor of Science degree in Engineering, Life Sciences, Computer Science, or related field; Master of Science degree preferred.
• 10 years of project/program management experience, with at least 5 in MES delivery within pharmaceutical or biotech manufacturing.
• Strong understanding of MES platforms such as Siemens Opcenter Execution Pharma, Werum PAS-X, Rockwell PharmaSuite, or equivalent.
• Deep knowledge of GMP, GAMP 5, 21 CFR Part 11, Annex 11, and relevant pharmaceutical regulations.
• Proven ability to manage multi-site or global system deployments in a regulated environment.
• Experience leading cross-functional teams including IT/OT, QA, validation, and manufacturing operations.
• Excellent communication, organizational, and leadership skills.
• PMP, PgMP, or equivalent certification preferred.

About us…Sterling Engineering…we offer FULL BENEFITS! As a Sterling Engineering W2 employee on contract, you receive a Full Employee Benefits Package that includes Paid Time Off, Paid Holidays, 3 Medical plans to choose from, Dental & Vision plans, 401(k) with a match, and an Employee Stock Ownership (ESOP) plan.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.