Lead Automation Engineer, MES & Digital Systems - Project Farma

PerkinElmer; North Carolina; Hybrid; USD 90,000 - 120,000; Full time

Job summary

PerkinElmer is seeking a Lead Automation Engineer specialized in MES and Digital Systems to manage design, implementation, and lifecycle of digital systems in biopharmaceutical manufacture.

Applicants should possess a bachelor's degree in engineering and have 9-12+ years of automation engineering experience. The role requires expertise in MES platforms and a commitment to compliance with GMP standards.

This position supports manufacturing environments focused on biologics and requires travel within the United States.

Qualifications

• 9-12+ years in automation engineering within GMP life sciences.
• Expert-level experience with multiple MES platforms.
• Hands-on experience in biologics and sterile/aseptic manufacturing.

Responsibilities

• Develop system architectures and data flows for manufacturing.
• Lead creation and approval of design documentation.
• Configure, program, and deploy digital systems in manufacturing.
• Serve as SME for system optimization and troubleshooting.
• Collaborate with cross-functional teams.

Skills

Experience with MES platforms

Automation Engineering

Troubleshooting

Leadership

Problem Solving

Education

Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical)

Tools

ERP

LIMS

CMMS

Job description

Job Title

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

Location

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

Job Summary

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.

Key Responsibilities

• 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 (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.
• Commissioning, Validation & GMP Compliance
  Detailed knowledge of FAT, SAT, IQ/OQ, and PQ protocols in alignment with GAMP5 and 21CFRPart11. 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.

Experience Required

• 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, GAMP5.
• Hands‑on experience in biologics and sterile/aseptic manufacturing environments.
• Understanding multisite standards for global manufacturers.

Preferred

• 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.

Travel & Work Requirements

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.

Equal Employment Opportunity

PerkinElmer 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. PerkinElmer is committed to a culturally diverse workforce.