Senior MES Engineer

Key Responsibilities

• Design and deliver MES solutions and standards independently or by leading a team.
• Act as a solution architect to conceptualize, detail, and implement MES systems.
• Develop MES strategies that integrate process knowledge, equipment, quality standards, and IT systems.
• Improve uptime, regulatory compliance, and process efficiency.
• Lead project management activities such as planning, budgeting, scheduling, task prioritization, tracking, and reporting.
• Manage project execution, financials, team communication, and profitability (up to $1M).
• Lead status meetings and provide regular updates.
• Oversee daily operations of assigned projects.
• Act as a technical lead and guide junior engineers and technicians.
• May serve as Project Manager for smaller-scale projects.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, or Applied Sciences is required.
• More than 10 years of MES experience is preferred.
• Proven deployment experience with Werum Client-X, Sepasoft, or POMS.
• Experience across full MES lifecycle: concept, design, implementation, testing, start-up, and commissioning.
• Lifesciences industry experience required.
• Familiarity with regulations such as cGMP and 21 CFR Part 11.
• Proficient in developing integrated EBR recipes using GAMP5, ISA-88 (S88), and ISA-95 (S95) standards.
• Strong understanding of manufacturing processes and MES system configuration.
• Knowledge of GMP warehouse and inventory management.
• Experience with external interfaces like DeltaV, SAP, LIMS, PI, and Maximo.
• Strong knowledge of historian and reporting systems.
• Experience with SQL, Oracle, or other relational databases.
• Knowledge of IT/OT networking.
• Strong technical writing and verbal communication skills.
• Proficiency in MS Office applications.
• Demonstrated experience leading MES project teams.
• Experience mentoring junior engineers.
• Able to provide professional references (subordinate, peer, manager).
• Willingness to travel up to 25%.