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.
2/2
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.
Experience Required
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 unders
Benefits
Health insuranceRemote work options
Additional Information
When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.
Job Title
Lead Automation Engineer, MES & Digital Systems - Project Farma
Location(s)
US Remote - AL, US Remote - CA, US Remote - CO, US Remote - DC, US Remote - IL, US Remote - IN, US Remote - MA, US Remote - MD, US Remote - MO, US Remote - NC, US Remote - NJ, US Remote - NY, US Remote - OH, US Remote - OR, US Remote - PA, US Remote - TX, US Remote - VA
Job Description
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. Key
Perkinelmer · Remote