Lead Automation Engineer, MES & Digital Systems - Project Farma

PerkinElmer•New York, MA

5d•Remote

About The Position

This is a full-time, salaried position with Project Farma, a PerkinElmer company. The successful candidate will reside in one of Project Farma's primary markets and be willing to travel domestically, to meet client project requests. The Lead Automation Engineer, MES & Digital Systems provides subject matter expertise in the design, implementation, and lifecycle management of digital systems across biologics, pharmaceutical, and novel therapy manufacturing facilities. This is a fully billable role, requiring experience with various MES platforms, Data Repositories, Serialization and integration to manufacturing applications (ERP, LIMS, CMMS, etc) and the ability to author, interpret, and lead documentation such as URS, FRS, Functional Narratives, and detailed system architecture designs. In addition to technical experience, the Lead Automation Engineer, MES & Digital Systems acts as client liaison during delivery of Project Farma service engagements. They are strategically responsible for client satisfaction through project delivery while maintaining and growing client relationships.

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.
We will not sponsor applicants for current or future work visas for this position.
This position may require significant travel to support project and business needs.
We cannot employ anyone with an invalid driver's license

Nice To Haves

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.

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.