DT&A - Lead Engineer, MES & Digital Systems

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. 

Project Farma’s purpose is to improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.  

All team members are expected to embody Project Farma’s values by being curious, personable, and unselfish, while maintaining a strong commitment to a Patient Focused and People First mindset. 

The Automation Engineer III and Lead Engineer is an advanced individual contributor with demonstrated depth in their technical discipline and a growing record of leading complex workstreams. This role applies strong subject‑matter expertise to solve high‑impact technical and operational challenges, supports technical decision‑making, and contributes to the evolution of standards, methods, or best practices within their area. They partner closely with project and people leaders—while remaining focused on technical delivery rather than formal people management. 

Key Responsibilities 

The Automation MES & Digital Systems Engineer provides subject matter expertise in the design, implementation, and lifecycle management of digital systems across biologics, pharmaceutical, and novel therapy manufacturing facilities. This role requires deep 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. 

MES Design & Architecture 

• 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. 

URS / FRS / Design Documentation 

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. 

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 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. 

Manufacturing & Operations Support 

• 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. 

Cross Functional Leadership 

• 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.