Lead MES & Digital Systems Engineer (Remote)

PerkinElmer

United States

Remote

USD 80,000 - 198,000

Full time

14 days+

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Job summary

PerkinElmer is seeking a Lead Automation Engineer, MES & Digital Systems to drive design, implementation, and lifecycle management of digital systems across biologics, pharmaceutical, and novel therapy manufacturing facilities. This is a billable role requiring expertise with MES platforms, data repositories, serialization, and ERP/LIMS/CMMS integration.

The candidate will serve as a client liaison during delivery, lead documentation and validation activities, and mentor junior engineers while

Qualifications

Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related).
Minimum 4-16+ years in automation engineering within GMP life sciences (biotech, pharma, ATMP).
Expert-level experience with 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

Responsibilities

Automation Design & Architecture: Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing (DCS, PLC/SCADA, MES, historians, network layers).
Automation Design & Architecture: Develop product recipe strategies across the full application layer of ERP, MES and DCS Batch.
Automation Design & Architecture: Detailed knowledge of Master data and how to define and control Master Data.
Automation Design & Architecture: Create ISA-88/ISA-95-aligned architecture diagrams, inc Application and Data Flow diagrams.
Automation Design & Architecture: 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
URS / FRS / Design Documentation: 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.
Digital System Implementation: Develop, modify, and test MES (eBR, RbE, eLogbooks, Equipment Tracking, Weigh & Dispense), LIMS, Serialization and CMMS application functionality.
Digital System Implementation: 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.
Commissioning, Validation & GMP Compliance: Ensure all changes meet data integrity requirements, change control processes, and validation lifecycle rules.
Commissioning, Validation & GMP Compliance: 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.
Manufacturing & Operations Support: Support 24/7 operations through structured root cause analysis and resolution of Digital System issues.
Manufacturing & Operations Support: 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.
Cross Functional Leadership: Manage vendors, system integrators, and OEMs; review design packages and ensure alignment with internal standards.
Cross Functional Leadership: Mentor junior engineers and act as technical SME during audits and regulatory inspections.