MES Engineer

About the role

Seeking a driven, business and technical oriented MES Engineer within our pharmaceutical operation reporting into Digital Systems organization. The MES Engineer plays a critical role in designing, developing, validating, and maintaining electronic batch records and recipes within MES platforms. This position is responsible for managing incident queues, resolving technical issues, and supporting change control activities in alignment with quality standards and GMP regulations.

Responsibilities

• Design, author, configure, and verify master batch records (MBRs), templates, and electronic batch records (EBRs) using MES platform (e.g. POMSnet Aquila).
• Support system integration activities, ensuring seamless data flow and interoperability between MES and other enterprise systems (such as ERP, LIMS, automation, and data management platforms via cross-functional teamwork.
• Analyze manufacturing requirements, collaborate with stakeholders (process engineers, business teams), and translate paper records into digital formats.
• Prioritize and execute support activities to align with project schedules and business needs.
• Author and maintain system and verification documentation, ensuring adherence to GMP, Global and internal quality standards.
• Demonstrate a high level of integrity and recognize the importance of quality control in pharmaceutical production.
• Perform comprehensive testing of new MES recipes and system changes.
• Troubleshoot MES issues, provide technical support during recipe execution, and resolve incidents in live production.
• Lead change management and continuous improvement initiatives to drive standardization, efficiency, and recipe optimization.
• Represent MES engineering on task forces, contribute to business projects, and influence technology strategy.
• Follow Environmental Health and Safety procedures and participate in incident investigations as required.
• Build rapport and communicate effectively with colleagues across and outside the MES team.
• Support business users, ensure their requirements are understood and delivered at or above expectations.
• The role will evolve to require Off Hours Support for MES systems.

Qualifications & Requirements

• Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 5+ years of significant engineering and/or operational experience. A post-graduate education/degree is desired, and may contribute towards the desired years of experience.
• Knowledge of MES solutions (POMSnet Aquila, PharmaSuite, Syncade, Werum PAS-X, or similar), and strong understanding of ISA-88/ISA-95 standards.
• Utilized C#, Visual Basic.NET, and JavaScript to perform MES coding and configuration tasks supporting manufacturing process optimization and operational efficiency.
• Has demonstrated competency within a discipline.
• Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Demonstrates judgment within defined procedures and practices to determine appropriate action.
• Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
• Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
• Works well with other engineers in a collaborative, fast-paced goal-driven environment.
• Possesses interpersonal skills to negotiate and reconcile differences.
• Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).
• Has demonstrated competency with financial systems and in fiscal control.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.