Lead Automation Engineer, MES & Digital Systems - Project Farma

Lead Automation Engineer, MES & Digital Systems – Project Farma

Locations:
Raleigh, North Carolina;
Albany, New York;
Annapolis, Maryland;
Austin, Texas;
Boston, Massachusetts;
Columbus, Ohio;
Denver, Colorado;
Harrisburg, Pennsylvania;
Indianapolis, Indiana;
Jefferson City, Missouri;
Montgomery, Alabama;
Remote.

This full‑time, salaried position requires the successful candidate to:

• Design, implement, and maintain digital systems (MES, DCS, PLC/SCADA, LIMS, ERP, CMMS) in biologics, pharmaceutical, and novel therapy manufacturing facilities.
• Create and manage URS, FRS, design specifications, functional/control narratives, recipe design documentation, and engineering guidelines.
• Configure, program, deploy, and support digital systems, including integration with OEM skids and manufacturing equipment.
• Lead FAT, SAT, IQ/OQ, PQ, and GMP validation activities in accordance with GAMP 5 and 21 CFR Part 11.
• Serve as SME for troubleshooting, performance enhancement, and lifecycle planning, covering 24/7 operations.
• Collaborate with IT/OT, process engineering, MSAT, quality, and capital project teams; manage vendors and system integrators.
• 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 of automation engineering experience in GMP life‑sciences manufacturing.
• Expertise with MES platforms, data repositories, serialization, and integration to ERP, LIMS, CMMS, etc.
• Strong knowledge of ISA‑88 batch control, ISA‑95 manufacturing hierarchy, and GAMP 5.
• Hands‑on experience in biologics and sterile/aseptic manufacturing environments.
• Understanding of multisite standards for global manufacturers.
• Strong communicator, able to influence across engineering, quality, IT/OT, and manufacturing.
• Structured thinker with 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 and are not eligible for sponsorship of work visas.

Project Farma may consider candidates with 7‑18+ years of relevant experience; compensation will be based on internal equity, location, and qualifications.

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, or veteran status or any other characteristics protected by applicable law. Perkin Elmer is committed to a culturally diverse workforce.