Lead Automation Engineer, MES & Digital Systems - Project Farma at PerkinElmer | New Jersey, US | Rezi

Lead Automation Engineer, MES & Digital Systems - Project Farma at PerkinElmer

Lead Automation Engineer, MES & Digital Systems - Project Farma

PerkinElmer · New Jersey, US

1 months ago

Lead Automation Engineer, MES & Digital Systems - Project Farma

PerkinElmer · New Jersey, US

2 months ago
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About the Role

PerkinElmer is an experienced and trusted leader in scientific solutions, providing critical support to customers globally. With over 80 years of advancing science and a mission to innovate for a healthier world, our team collaborates with various sectors to deliver analytical solutions and services.

Responsibilities

  • Develop system architectures and data flows for manufacturing facilities.
  • Create ISA-88/ISA-95-aligned architecture diagrams.
  • Ensure architecture supports scalability, cybersecurity, data integrity, and multi-product flexibility.
  • Lead the creation, review, and approval of URS, FRS, DS/DDS, Functional & Control Narratives, Recipe Design Documentation, and Automation Standards.
  • Work cross-functionally to translate process requirements into robust digital system design documents.
  • Configure, program, and deploy Digital Systems within the manufacturing environment.
  • Develop, modify, and test MES, LIMS, Serialization, and CMMS application functionality.
  • Support integration of OEM skids.
  • 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.
  • Mentor junior engineers and act as technical SME during audits and regulatory inspections.

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.
  • 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.
  • Applicants must be authorized to work in the United States on a full-time basis.
  • This position may require significant travel to support project and business needs.
  • We cannot employ anyone with an invalid driver's license.

Skills

  • MES platforms
  • Data Repositories
  • Serialization
  • ERP integration
  • LIMS integration
  • CMMS integration
  • URS authoring
  • FRS authoring
  • Functional Narratives
  • System architecture design
  • DCS
  • PLC/SCADA
  • MES
  • Historians
  • Network layers
  • Product recipe strategies
  • ERP Batch
  • MES Batch
  • DCS Batch
  • Master data management
  • ISA-88
  • ISA-95
  • eBR
  • RbE
  • eLogbooks
  • Equipment Tracking
  • Weigh & Dispense
  • Bioreactor integration
  • Chromatography system integration
  • Filtration skid integration
  • CIP/SIP integration
  • Fill finish equipment integration
  • FAT
  • SAT
  • IQ/OQ
  • PQ
  • GAMP 5
  • 21 CFR Part 11
  • Data integrity
  • Change control
  • Validation lifecycle
  • Deviation investigations
  • CAPA
  • Risk assessments
  • Troubleshooting
  • System optimization
  • Batch failure analysis
  • Performance enhancements
  • Root cause analysis
  • Lifecycle planning
  • IT/OT collaboration
  • Process engineering collaboration
  • MSAT collaboration
  • Quality collaboration
  • Capital project collaboration
  • Vendor management
  • System integrator management
  • OEM management
  • Mentorship

Location

  • 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

Work Type

  • Full-time
  • Salaried
  • Remote
  • Travel domestically

Experience Level

  • Lead
  • 9-12+ years
  • 7 - 18+ years

Education Level

  • Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related)

Salary/Compensations

  • The annual compensation range for this full-time position will range broadly.

About the Company

  • PerkinElmer is an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers.
  • 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.
  • Project Farma is a PerkinElmer company.
  • We are a unique team of 5,000+ global colleagues who come to work every day knowing we’re making a difference.
  • Through innovation, collaboration, and believing in our mission, we strive to create an inspiring and inclusive culture for our employees, so that they can be their best and, together, create a better tomorrow.

Equal 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, or veteran status or any other characteristics protected by applicable law.
  • PerkinElmer is committed to a culturally diverse workforce.