Lead Automation Engineer, MES & Digital Systems - Project Farma

Job Title

Lead Automation Engineer, MES & Digital Systems (Project Farma)

• US Remote - AL, CA, CO, DC, IL, IN, MA, MD, MO, NC, NJ, NY, OH, OR, PA, TX, VA

This full‑time, salaried role provides subject matter expertise in design, implementation, and lifecycle management of digital systems across biologics, pharmaceutical, and novel therapy manufacturing facilities. It is fully billable and requires expertise with MES platforms, data repositories, serialization, and integration to manufacturing applications.

• Automation Design & Architecture
  Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing (DCS, PLC/SCADA, MES, historians, network layers). Design 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.
• URS / FRS / Design Documentation
  Lead creation, review, and approval of URS, FRS, DS/DDS, 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.
• Digital System Implementation
  Configure, program, and deploy digital system within the manufacturing environment. Develop, modify, and test MES (e , 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.
• Commissioning, Validation & GMP Compliance
  Detailed knowledge of FAT, SAT, IQ/OQ, and PQ protocols in alignment with GAMP5 and 21
  
  CFRPart
  11. Lead deviation investigations, CAPAs, and risk assessments related to digital systems. Ensure changes meet data integrity requirements, change control processes, and validation lifecycle rules.
• Manufacturing & Operations Support
  Serve as SME for troubleshooting, system optimization, batch failure analysis, and performance enhancements. Support 24/7 operations through root‑cause analysis and resolution of digital system issues. Develop long‑term lifecycle plans for upgrades, patches, and system expansions.
• Cross‑Functional Leadership
  Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams. Manage vendors, system integrators, and OEMs; review design packages ensuring alignment with internal standards. Mentor junior engineers and act as technical SME during audits and regulatory inspections.

• Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related).
• 9‑12+ years in automation engineering within GMP life sciences (biotech, pharma, ATMP).
• Expert‑level experience with multiple 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, GAMP
  5.
• Hands‑on experience in biologics and sterile/aseptic manufacturing environments.
• Understanding multisite standards for global manufacturers.

• 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.

Requires domestic travel to meet client project requests. Must be authorized to work in the United States on a full‑time basis. Company will not sponsor visas. Valid driver’s license is required.

Perkin Elmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, veteran status or any other characteristics protected by applicable law. Perkin Elmer is committed to a culturally diverse workforce.