Lead Engineer, MES – Digital Systems

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $100k - $130k / year

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

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PerkinElmer

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1938

🍽️ Food & Beverage

🏥 Healthcare

💼 Consulting

Food & Beverage • Healthcare • Consulting

PerkinElmer is a global leader in providing analytical and testing solutions for a wide range of industries, including pharmaceuticals, food safety, environmental analysis, and industrial testing. The company offers advanced equipment and consumables, including mass spectrometers, chromatography instruments, and spectroscopy systems. With over 85 years of experience, PerkinElmer is committed to innovation and dedicated to partnering with laboratories worldwide to enhance scientific discovery and ensure product quality and safety. Their services support industries like healthcare, food and beverage, environmental testing, and industrial applications, helping clients meet compliance and quality standards.

📋 Description

• Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing systems • Develop product recipe strategies across ERP, MES, and DCS Batch application layers • Define and control master data • Create ISA-88/ISA-95-aligned architecture and application/data-flow diagrams • Ensure scalability, cybersecurity, data integrity, and multi-product flexibility • Lead creation, review, and approval of URS, FRS, DS/DDS, functional and control narratives, recipe documentation, standards, and engineering guidelines • Translate process requirements into digital system design documents • Configure, program, and deploy digital systems in manufacturing environments • Develop, modify, and test MES, LIMS, Serialization, and CMMS functionality • Support integration of OEM skids and manufacturing equipment • Lead or support FAT, SAT, IQ/OQ, and PQ activities • Ensure changes comply with data integrity, change control, and validation lifecycle requirements • Lead deviation investigations, CAPAs, and risk assessments • Troubleshoot and optimize systems, analyze batch failures, and enhance performance • Support 24/7 operations through root cause analysis and issue resolution • Develop lifecycle plans for upgrades, patches, and system expansions • Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams • Manage vendors, system integrators, and OEMs • Mentor junior engineers and serve as technical SME during audits and regulatory inspections

🎯 Requirements

• Bachelor’s Degree in Life Science, Engineering, or related discipline, or equivalent work experience • 4+ years / 7+ years in Digital Manufacturing Systems within GMP life sciences, including biotech, pharma, or ATMP • Expert-level experience with MES platforms, Data Repositories, Serialization, and integrations with ERP, LIMS, and CMMS • Deep knowledge of MES design, implementation, and lifecycle management • Ability to author, interpret, and lead URS, FRS, Functional Narratives, and system architecture documentation • Knowledge of ISA-88 and ISA-95 architecture • Knowledge of master data definition and control • Experience with eBR, RbE, eLogbooks, Equipment Tracking, and Weigh & Dispense functionality • Knowledge of FAT, SAT, IQ/OQ, and PQ protocols aligned with GAMP 5 and 21 CFR Part 11 • Experience with data integrity, change control, validation lifecycle, deviation investigations, CAPAs, and risk assessments • Willingness to travel as required for client project assignments • Strong communication and influencing skills across engineering, quality, IT/OT, and manufacturing • Advanced troubleshooting and problem-solving skills • Ability to manage multiple priorities in a high-pressure, regulated environment • Demonstrated leadership and mentorship abilities • Applicants must be authorized to work in the United States on a full-time basis • No current or future work visa sponsorship • Must have a valid driver's license

🏖️ Benefits

• Full-time salaried position • Remote work in Massachusetts • Support from a global service network and distribution centers • Opportunity to contribute to life sciences projects across the full project lifecycle • Diverse, inclusive, and culturally diverse workforce • Equal opportunity employer