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DT&A - Lead Engineer, MES & Digital Systems

Newperkinelmer

Remote · US$100k – $130k

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About this role

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 DT&A - Lead Engineer, MES & Digital Systems Location(s) US Remote - MA 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.  

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.  

Attributes for Success   • Technical Delivery : Applies advanced technical knowledge and professional   expertise    

• Innovation & Continuous Improvement : Seeks better ways, adapts to change and champions   new ideas .   

• Customer Focus & Professionalism :   Represents   PF with consistent professionalism,   appropriate escalation   and respect for internal stakeholders, even during high stress delivery situations   

• Integrity & Humility :   Demonstrates   self-awareness   and puts PF missi

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