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, VAJob 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 & ArchitectureDevelop 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 DocumentationLead 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 ImplementationConfigure, 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 ComplianceDetailed 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 SupportServe 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 LeadershipCollaborate 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.#J-18808-Ljbffr