Lead Automation Engineer, MES & Digital Systems - Project Farma

PerkinElmer, a leader in scientific solutions, is seeking a Lead Automation Engineer, MES & Digital Systems for Project Farma. The role involves providing expertise in the design and implementation of digital systems for manufacturing facilities, ensuring client satisfaction, and leading project delivery.

Responsibilities:

• 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
• Detailed knowledge of Master data and how to define and control Master Data
• Create ISA-88/ISA-95-aligned architecture diagrams, inc Application and Data Flow diagrams
• 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), Automation Standards & Engineering Guidelines
• Work cross functionally to translate process requirements into robust digital system design documents
• Configure, program, and deploy Digital System within the manufacturing environment
• Develop, modify, and test MES (eBR, RbE, eLogbooks, Equipment Tracking, Weigh & Dispense), LIMS, Serialization and CMMS application functionality
• Support integration of OEM skids: bioreactors, chromatography systems, filtration skids, CIP/SIP, and fill finish equipment
• Detailed knowledge of FAT, SAT, IQ/OQ, and PQ protocols in alignment with GAMP 5 and 21 CFR Part 11
• Ensure all changes meet data integrity requirements, change control processes, and validation lifecycle rules
• Lead deviation investigations, CAPAs, and risk assessments related to Digital systems
• Serve as SME for troubleshooting, system optimization, batch failure analysis, and performance enhancements
• Support 24/7 operations through structured root cause analysis and resolution of Digital System issues
• Develop long-term lifecycle plans for upgrades, patches, and system expansions
• Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams to deliver integrated system solutions
• Manage vendors, system integrators, and OEMs; review design packages and ensure alignment with internal standards
• Mentor junior engineers and act as technical SME during audits and regulatory inspections

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
• This position may require significant travel to support project and business needs
• We cannot employ anyone with an invalid driver's license
• Strong communicator and influencer across engineering, quality, IT/OT, and manufacturing
• Structured thinker with advanced troubleshooting and problem solving skills
• Skilled at managing multiple priorities in a high pressure, regulated environment
• Demonstrated leadership and mentorship abilities