MES System Owner PC 1534

Miltenyi Biotec•Gaithersburg, MD

About The Position

We are seeking an experienced and detail-oriented MES (Manufacturing Execution System) System Owner to take ownership of our MES platform within a regulated GMP manufacturing environment. This role is responsible for the governance, lifecycle management, compliance, and continuous improvement of the MES system to ensure reliable, efficient, and compliant manufacturing operations aligned with GMP, FDA 21 CFR Part 11, and other regulatory requirements. The ideal candidate will act as the bridge between operations (MFG./ QC), IT, QA, and validation, driving digital excellence across production sites. This role plays a key part in digitalizing GMP manufacturing processes and enhancing operational efficiency through well-structured and compliant MES system.

Requirements

Bachelor's in computer science, Engineering, Life Sciences, or related field
Minimum 8 years of experience working with MES systems in the pharmaceutical or biotech industry.
Experience integrating MES with ERP (e.g., SAP), manufacturing/QC equipment.
Deep understanding of GMP, FDA 21 CFR Part 11, GAMP 5, and CSV (Computer System Validation) requirements.
Experience with industry-standard MES platforms.
Strong understanding of pharmaceutical manufacturing processes (batch production, electronic batch records, etc.).
Experience in technical support or implementation of Manufacturing Execution Systems (MES) in a GMP manufacturing environment.
Basic understanding of GMP manufacturing / guidelines, software/workflow validation and compliance requirements
Excellent problem-solving, communication, and cross-functional collaboration skills.
Strong understanding of manufacturing processes and workflows, with the ability to translate business requirements into MES solutions.
Understanding of database systems and programming languages is advantageous.
Strong ability to diagnose and resolve MES software and integration issues.
Meticulous in configuring, testing, documenting, and delivering high-quality technical support.
Flexible in dynamic environments; effective in prioritizing tasks and managing projects.
Committed to ongoing learning of MES technology and industry practices, strong understanding of GMP manufacturing and compliance standards.
Excellent verbal and written skills; ability to work effectively with cross-functional teams and stakeholders.
Willingness to travel occasionally for on-site support and training engagements, as required.

Responsibilities

System Ownership & Governance Act as the designated System Owner for the MES platform, accountable for its functionality, performance, compliance, and audit readiness.
Define and maintain the MES system roadmap, ensuring alignment with manufacturing strategy and corporate digital initiatives.
Ensure system compliance with GMP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and internal quality standards.
Validation & Compliance Own the validation lifecycle of the MES system including URS, risk assessments, IQ/OQ/PQ documentation, and change control.
Collaborate with Quality Assurance and Validation teams to maintain a validated state for the system at all times.
Lead audit readiness activities and support regulatory inspections involving the MES system.
Operational Support & Change Management Oversee day-to-day MES operations, system maintenance, and support issue resolution to minimize production disruptions.
Coordinate and manage system upgrades, patches, and enhancements following change control procedures.
Identify and implement continuous improvement opportunities to optimize MES functionality, workflows, and user experience.
Project Leadership & Collaboration Lead or support MES-related projects such as new site rollouts, integrations with ERP, LIMS, and automation systems.
Serve as a key liaison between manufacturing, quality, IT, automation, and system vendors.
Review MES-related SOPs, training materials, and user documentation.
Work with operations team to create a culture of accountability, ownership, and continuous improvement.
Work across departments and/or sites.
Work with process engineers and manager to align the priorities of the team with those of the department.
Able to work independently; shows initiative and able to work with all levels of staff.
Able to participate in an on-call environment to meet business continuity requirements, including weekends and holidays if required.