MES Program Lead: Strategy, Validation & Digital Ops

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

Benefits offered by this job

6% 401(k) company match

Health care options

Job summary

Padagis-LL is seeking an MES Program Lead in Minneapolis to own the MES/EBR program strategy and governance. You will partner with Manufacturing, QA, Engineering, Validation, IT, and external vendors to ensure reliable compliant digital manufacturing processes and data integrity.

The role oversees governance, lifecycle management, and continuous improvement while coordinating validation, change control, and regulatory activities to deliver value and right-first-time performance.

Qualifications

• Bachelor’s degree in engineering or a related technical discipline.
• Minimum of six (6) years of experience in highly regulated manufacturing environments.
• Demonstrated GMP and Data Integrity knowledge.
• Strong CSV methodologies and lifecycle documentation experience.
• Experience leading complex cross-functional projects.
• Experience managing change control, deviations, CAPA, and regulatory activities.
• Strong problem-solving, communication, and stakeholder management skills.

Responsibilities

• Lead MES strategy and program governance including roadmaps, milestones, budgets, and stakeholder reporting.
• Oversee MES system development, deployment, and lifecycle management, including EBRs, recipes, workflows, and configurations.
• Ensure GMP, data integrity, cybersecurity, and regulatory compliance; coordinate CSV activities and documentation.
• Collaborate across Manufacturing, Quality, Engineering, IT, Supply Chain, Regulatory Affairs, and vendors; lead investigations and corrective actions.
• Drive continuous improvement; create SOPs, training materials, and system administration procedures; promote system adoption and best practices across site.

Skills

GMP knowledge

CSV knowledge

Cross-functional leadership

Change control

CAPA processes

Regulatory compliance

Stakeholder management

Problem solving

Communication

Education

Bachelor’s degree in Engineering, Information Systems, Computer Science, Manufacturing, Pharmaceutical Sciences, or related

Job description

Padagis-LL is seeking an MES Program Lead in Minneapolis to own the MES/EBR program strategy and governance. You will partner with Manufacturing, QA, Engineering, Validation, IT, and external vendors to ensure reliable compliant digital manufacturing processes and data integrity.

The role oversees governance, lifecycle management, and continuous improvement while coordinating validation, change control, and regulatory activities to deliver value and right-first-time performance.