Manufacturing Execution System (MES) Program Lead

Padagis; Minneapolis (MN); On-site; USD 110,000 - 135,000; Full time

Benefits offered by this job

Bonus program

Long-term incentive

401k matching

Health benefits

Job summary

Padagis is hiring a MES Program Lead in Minneapolis to own the MES/EBR strategy, governance, and delivery. You will partner with Manufacturing, Quality, IT, Validation, and external vendors to ensure compliant, scalable digital manufacturing solutions that improve data visibility and batch throughput.

The role emphasizes CSV validation, GMP compliance, risk management, and continuous improvement, with a 10% annual bonus target and a 10% long‑term incentive target, plus a robust benefits program

Qualifications

• Bachelor’s degree in a technical field (engineering, information systems, CS, manufacturing, or pharma).
• 6+ years in regulated manufacturing environments.
• GMP and Data Integrity experience.
• CSV methodologies and lifecycle documentation know-how.
• Experience leading cross-functional projects and regulatory activities.
• Experience with change control, deviations, CAPA processes, and regulatory compliance.

Responsibilities

• Serve as site MES SME and business owner for EBR systems.
• Develop and execute the site MES roadmap aligned with objectives and digital initiatives.
• Lead MES governance: planning, prioritization, risk management, stakeholder engagement, status reporting.
• Oversee milestones, budgets, timelines, and business outcomes.

Skills

Cross-functional leadership

CSV knowledge

Data integrity

Regulatory compliance

GMP knowledge

Education

Bachelor's degree in Engineering/Info Systems/CS/Manufacturing/Pharmaceutical Sciences

Tools

MES

EBR systems

ERP integration

Job description

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. This position is responsible for driving the strategy, implementation, governance, validation, and continuous improvement of digital manufacturing solutions that support operational excellence, regulatory compliance, and business objectives.

The MES Program Lead partners closely with Manufacturing, Quality, Engineering, Validation, IT, Supply Chain, Regulatory Affairs, and external vendors to ensure electronic manufacturing processes are reliable, compliant, scalable, and capable of supporting the organization's digital transformation initiatives. The role plays a critical leadership function in maximizing the value of MES capabilities through improved operational efficiency, enhanced data visibility, reduced batch review cycle times, and increased right-first-time performance.

The base salary range for this opportunity is $110,000 - $135,000 depending on education, experience, and certifications. This role includes a 10% annual bonus target and 10% long-term incentive target, as well as eligibility for the robust Padagis employee benefits program featuring affordable quality health care options and a 6% annual contribution to 401k as just two of the highlights of the program.

Job duties

MES Strategy & Program Leadership - 25%

• Serve as the site MES Subject Matter Expert (SME) and business owner for Electronic Batch Record (EBR) systems.
• Develop and execute the site's MES roadmap aligned with business objectives and digital transformation initiatives.
• Lead MES governance activities including project planning, prioritization, risk management, stakeholder engagement, and status reporting.
• Ensure successful achievement of project milestones, budgets, timelines, and business outcomes.

MES System Development & Lifecycle Management - 25%

• Lead implementation, deployment, enhancement, and lifecycle management of MES solutions.
• Own 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 sustainable, scalable solutions that meet operational and compliance requirements.

Compliance, Validation & Data Integrity - 20%

• Ensure MES systems comply with GMP requirements, Data Integrity principles, cybersecurity standards, and regulatory expectations.
• Coordinate Computer System Validation (CSV) activities including:
  • User Requirements Specifications (URS)
  • Functional Specifications
  • Risk Assessments
  • Test Protocols
  • Traceability Matrices
  • Validation Reports
• Manage change controls, deviations, CAPAs, and audit readiness activities associated with MES systems.

Cross-Functional Collaboration & Operational Support - 15%

• Partner with Manufacturing, Quality, Engineering, Supply Chain, Regulatory Affairs, IT, and vendors to translate business requirements into effective digital solutions.
• Provide technical leadership during investigations involving MES-related deviations, system issues, or data discrepancies.
• Perform impact assessments and support development of corrective and preventative actions when required.
• Support integration efforts between MES, ERP, quality systems, automation platforms, and manufacturing reporting tools.

Continuous Improvement & User Enablement - 15%

• 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.

Required qualifications

• Bachelor's degree in Engineering, Information Systems, Computer Science, Manufacturing, Pharmaceutical Sciences, or a related technical discipline.
• Minimum of six (6) 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 (CSV) 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.

Preferred qualifications

• 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.