MES System Owner *PC 1534

Your Role:

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.

Essential Duties and 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.

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; Or a combination of education and experience.
• 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.

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.
• 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.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds (dual lift). Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail. Must be able to travel routinely by car and plane.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $129,300- $140,700/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biotec, Inc is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.