For 85 years, we have pushed the boundaries of science with a clear purpose – to help our customers achieve theirs.
Lead Automation Engineer, MES – Digital Systems
Location
New Jersey + 3 moreAll locations: New Jersey | New York | North Carolina | Massachusetts
Posted
17 days ago
Salary
0
Seniority
Senior
Job Description
Lead Automation Engineer, MES – Digital Systems
PerkinElmer
• Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing (DCS, PLC/SCADA, MES, historians, network layers) • Develop product recipe strategies across the full application layer of ERP, MES and DCS Batch • Ensure architecture supports scalability, cybersecurity, data integrity, and multi-product flexibility • Lead the creation, review, and approval of: URS (User Requirements Specifications), FRS (Functional Requirements Specifications), DS / DDS (Design Specifications), Functional & Control Narratives, Recipe Design Documentation (ISA-88 compliant) • Configure, program, and deploy Digital System within the manufacturing environment • Support integration of OEM skids: bioreactors, chromatography systems, filtration skids, CIP/SIP, and fill finish equipment • Lead deviation investigations, CAPAs, and risk assessments related to Digital systems • Serve as SME for troubleshooting, system optimization, batch failure analysis, and performance enhancements • Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams to deliver integrated system solutions • Mentor junior engineers and act as technical SME during audits and regulatory inspections
Job Requirements
- Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related)
- Minimum 9-12+ years in automation engineering within GMP life sciences (biotech, pharma, ATMP)
- Expert-level experience with various MES platforms, Data Repositories, Serialization and integration to manufacturing applications (ERP, LIMS, CMMS, etc)
- Proven ability to author, interpret, and own URS/FRS/DS documentation
- Experience designing system applications and data flows across the full spectrum of manufacturing applications
- Strong understanding of ISA-88 batch control, ISA-95 manufacturing hierarchy, and GAMP 5
- Hands-on experience supporting biologics and sterile/aseptic manufacturing environments
- Understanding multisite standards for global manufacturers
- Applicants must be authorized to work in the United States on a full-time basis.
Benefits
- Health insurance
- 401(k) plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
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