Manufacturing Execution System (MES) Program Lead

Padagis•Minneapolis, MN

About The Position

The MES Program Lead serves as the site owner, subject matter expert, and technical lead for the Manufacturing Execution System (MES) and Electronic Batch Record (EBR) program. The role drives strategy, implementation, governance, validation, and continuous improvement of digital manufacturing solutions that support operational excellence, regulatory compliance, and business objectives. It partners with Manufacturing, Quality, Engineering, Validation, IT, Supply Chain, Regulatory Affairs, and external vendors to ensure electronic manufacturing processes are reliable, compliant, scalable, and supportive of digital transformation initiatives. The position aims to maximize MES capabilities through improved operational efficiency, enhanced data visibility, reduced batch review cycle times, and increased right-first-time performance. The base salary range is $110,000–$135,000, depending on education, experience, and certifications. The role includes a 10% annual bonus target and a 10% long-term incentive target. Employees are eligible for the Padagis benefits program, including affordable health care options and a 6% annual contribution to 401k. The role leads MES strategy and program governance; system development and lifecycle management; compliance, validation, and data integrity; cross-functional collaboration and operational support; and continuous improvement and user enablement.

Requirements

Bachelor’s degree in Engineering, Information Systems, Computer Science, Manufacturing, Pharmaceutical Sciences, or a related technical discipline.
At least six years of experience in pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
Demonstrated experience with GMP regulations and Data Integrity requirements.
Strong knowledge of Computer System Validation methodologies and lifecycle documentation.
Experience leading complex cross-functional projects involving business and technical stakeholders.
Experience managing change control, deviation management, CAPA processes, and regulatory compliance activities.
Strong problem-solving, communication, and stakeholder management skills.

Nice To Haves

Direct experience implementing and supporting Manufacturing Execution Systems (MES).
Experience with Electronic Batch Record (EBR) systems.
Experience leading digital transformation initiatives within manufacturing operations.
Knowledge of MES integration with ERP, automation, quality management, and data reporting systems.
Project Management certification (PMP or equivalent).
Experience supporting FDA-regulated pharmaceutical manufacturing facilities.

Responsibilities

Serve as the site MES subject matter expert and business owner for Electronic Batch Record systems.
Develop and execute the site's MES roadmap aligned with business objectives and digital transformation initiatives.
Lead MES governance, including project planning, prioritization, risk management, stakeholder engagement, and status reporting.
Ensure project milestones, budgets, timelines, and business outcomes are achieved.
Lead implementation, deployment, enhancement, and lifecycle management of MES solutions.
Own the creation, review, testing, deployment, and maintenance of electronic batch records, recipes, workflows, master data, and system configurations.
Support system upgrades, releases, integrations, and ongoing performance optimization.
Ensure MES solutions are sustainable, scalable, and meet operational and compliance requirements.
Ensure MES systems comply with GMP requirements, Data Integrity principles, cybersecurity standards, and regulatory expectations.
Coordinate Computer System Validation activities, including URS, functional specifications, risk assessments, test protocols, traceability matrices, and validation reports.
Manage change controls, deviations, CAPAs, and audit readiness activities associated with MES systems.
Partner with relevant business and technical functions and vendors to translate business requirements into digital solutions.
Provide technical leadership during investigations involving MES-related deviations, system issues, or data discrepancies.
Perform impact assessments and support corrective and preventative action development when required.
Support integration efforts between MES, ERP, quality systems, automation platforms, and manufacturing reporting tools.
Identify opportunities to improve manufacturing efficiency, operational visibility, electronic workflows, and right-first-time performance.
Create and maintain SOPs, work instructions, training materials, and system administration procedures.
Deliver MES training and coaching to manufacturing and support personnel.
Drive adoption of system enhancements and best practices across the site.