MES Program Lead: Digital Manufacturing & EBR Strategist

Padagis LLC; Minnesota; Sur place; USD 110 000 - 135 000; Plein temps

Avantages offerts par ce poste

Health care options

401k contribution

Bonus target

Long-term incentive

Résumé du poste

Padagis is seeking an experienced Manufacturing Execution System (MES) Program Lead at the Minneapolis site to own the MES/EBR program, drive strategy, governance, validation, and continuous improvement of digital manufacturing solutions across operations.

You will partner with Manufacturing, Quality, Engineering, Validation, IT, Supply Chain, Regulatory Affairs, and vendors to ensure compliant, scalable MES capabilities that enhance data visibility and right-first-time performance.

Qualifications

• Bachelor’s degree in Engineering, Information Systems, Computer Science, Manufacturing, Pharmaceutical Sciences, or related discipline.
• Minimum of six (6) years in regulated manufacturing environments.
• Demonstrated GMP and Data Integrity experience.
• Strong knowledge of CSV methodologies and lifecycle documentation.
• Experience leading cross-functional projects with business and technical stakeholders.
• Experience managing change control, deviations, CAPA, and regulatory activities.
• Strong problem-solving and stakeholder management skills.

Responsabilités

• Serve as the MES SME and business owner for EBR systems.
• Develop and execute the site's MES roadmap aligned with business objectives and digital initiatives.
• Lead MES governance activities including planning, prioritization, risk management, stakeholder engagement, and reporting.
• Ensure project milestones, budgets, timelines, and business outcomes are achieved.
• Lead deployment, enhancements, and lifecycle management of MES solutions.
• Manage electronic batch records, recipes, workflows, master data, and system configurations.
• Support upgrades, releases, integrations, and performance optimization.
• Ensure MES solutions are sustainable and compliant.
• Partner with Manufacturing, Quality, Engineering, IT, Supply Chain, Regulatory Affairs, and vendors to translate requirements.
• Provide technical leadership during investigations involving MES deviations, system issues, or data discrepancies.
• Support corrective and preventive actions and integrations with MES, ERP, QA, automation, and reporting systems.
• Identify opportunities to improve efficiency and visibility; create SOPs, training materials, and system procedures.
• Deliver MES training and coaching to manufacturing and support staff; drive adoption of enhancements.

Connaissances

GMP compliance

Data Integrity

Project leadership

Cross-functional leadership

Regulatory liaison

Formation

Bachelor's degree

Outils

CSV lifecycle tools

Description du poste

Padagis is seeking an experienced Manufacturing Execution System (MES) Program Lead at the Minneapolis site to own the MES/EBR program, drive strategy, governance, validation, and continuous improvement of digital manufacturing solutions across operations.

You will partner with Manufacturing, Quality, Engineering, Validation, IT, Supply Chain, Regulatory Affairs, and vendors to ensure compliant, scalable MES capabilities that enhance data visibility and right-first-time performance.