Lead Engineer, MES – Digital Systems

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Design system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing systems.

• Formulate product recipe strategies across ERP, MES, and DCS Batch application layers.

• Define and manage master data control.

• Develop ISA-88/ISA-95-compliant architecture and application/data-flow diagrams.

• Ensure scalability, cybersecurity, data integrity, and flexibility for multi-product environments.

• Oversee the creation, review, and approval of URS, FRS, DS/DDS, functional and control narratives, recipe documentation, standards, and engineering guidelines.

• Convert process requirements into digital system design documentation.

• Configure, program, and implement digital systems in manufacturing settings.

• Develop, modify, and test functionalities of MES, LIMS, Serialization, and CMMS.

• Facilitate the integration of OEM skids and manufacturing equipment.

• Lead or assist in FAT, SAT, IQ/OQ, and PQ activities.

• Ensure that changes adhere to data integrity, change control, and validation lifecycle standards.

• Manage deviation investigations, CAPAs, and risk assessments.

• Diagnose and optimize systems, analyze batch failures, and improve performance.

• Provide support for 24/7 operations through root cause analysis and issue resolution.

• Create lifecycle plans for upgrades, patches, and system expansions.

• Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams.

• Supervise vendors, system integrators, and OEMs.

• Mentor junior engineers and act as a technical SME during audits and regulatory inspections.

⛳️ Requirements

• Bachelor’s Degree in Life Science, Engineering, or a related field, or equivalent professional experience.

• 4+ years / 7+ years in Digital Manufacturing Systems within GMP life sciences, including biotech, pharmaceutical, or ATMP.

• Expert-level proficiency with MES platforms, Data Repositories, Serialization, and their integration with ERP, LIMS, and CMMS.

• In-depth knowledge of MES design, implementation, and lifecycle management.

• Capability to author, interpret, and lead URS, FRS, Functional Narratives, and system architecture documentation.

• Familiarity with ISA-88 and ISA-95 architecture.

• Understanding of master data definition and control.

• Experience with eBR, RbE, eLogbooks, Equipment Tracking, and Weigh & Dispense functionalities.

• Knowledge of FAT, SAT, IQ/OQ, and PQ protocols in alignment with GAMP 5 and 21 CFR Part 11.

• Experience in data integrity, change control, validation lifecycle, deviation investigations, CAPAs, and risk assessments.

• Willingness to travel as needed for client project assignments.

• Excellent communication and influencing skills across engineering, quality, IT/OT, and manufacturing sectors.

• Advanced troubleshooting and problem-solving capabilities.

• Ability to manage multiple priorities in a high-pressure, regulated environment.

• Proven leadership and mentoring skills.

• Candidates must be authorized for full-time work in the United States.

• No current or future sponsorship for work visas.

• A valid driver's license is required.

🏝️ Benefits

• Full-time salaried employment.

• Remote work opportunity within Massachusetts.

• Backing from a global service network and distribution centers.

• Chance to contribute to life sciences projects throughout the complete project lifecycle.

• A diverse, inclusive, and culturally rich workforce.

• Equal opportunity employer.