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.
