DT&A - Manager, MES & Digital Systems

The DT&A Managerisan advanced individual contributor withdemonstrateddepth in their technical discipline and a growing record of leading complex workstreams. This role applies strong subject-matterexpertiseto 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.Theypartner closely with project and people leaders-whileremainingfocused on technical delivery rather than formal people management., The AutomationMES & Digital SystemsEngineer provides subject matterexpertisein 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,Serializationand integration to manufacturing applications (ERP, LIMS, CMMS,etc) and the ability to author, interpret, and lead documentation such asURS,FRS,Functional Narratives, and detailedsystem architecture designs.

MESDesign & Architecture

• Developsystem architectures and data flowsfor biologics, pharmaceutical, and advanced therapy manufacturing (DCS, PLC/SCADA, MES, historians, network layers).
• Develop product recipe strategies across the full application layer of ERP,MESand DCS Batch.
• Detailed knowledge of Master data and how to define and control Master Data.
• CreateISA-88/ISA-95-aligned architecture diagrams,incApplication and Data Flow diagrams.
• Ensure architecture supports scalability, cybersecurity, data integrity, andmulti-productflexibility.

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 crossfunctionally 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 fillfinishequipment.

Commissioning, Validation & GMP Compliance

• Detailed knowledge ofFAT,SAT,IQ/OQ, andPQprotocols in alignment with GAMP 5 and 21 CFR Part 11.
• Ensure all changes meet data integrity requirements, change control processes, andvalidationlifecycle 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 professionalexpertise
• Innovation & Continuous Improvement: Seeks better ways, adapts to change and championsnew ideas.
• Customer Focus & Professionalism:RepresentsPF with consistent professionalism,appropriate escalationand respect for internal stakeholders, even during high stress delivery situations
• Integrity & Humility:Demonstratesself-awarenessand puts PF mission above ego
• Collaboration & Communication:Communicates clearly and proactively and drives transparent alignment with clients.
• Project Execution: Delivers reliably, managesprioritiesand drives forhigh qualityoutcomes
• Growth Mindset: Shows openness tonew ideas,feedbackand change

• Education:Bachelor’s Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up,CapEx/OpExproject management and/or comparable military experience.
• 10-13 years in Digital Manufacturing Systems within GMP life sciences (biotech, pharma, ATMP).Expert-level experience with various MES platforms, Data Repositories,Serializationand integrationtomanufacturing applications (ERP, LIMS, CMMS,etc).
• Willing to travel asrequiredfor client project assignments.

Other Preferred

• Strongcommunicatorandinfluenceracross engineering, quality, IT/OT, and manufacturing.
• Structured thinker with advanced troubleshooting andproblem solvingskills.
• Skilled at managing multiple priorities in a high pressure, regulated environment.
• Demonstrated leadership and mentorship abilities.

Project Farmais 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.

Applicants mustbe authorized towork in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver’s license.

The annual compensation range for this full-time position is $140000 - 170,000. The final base pay offered to the successful candidate will bedeterminedby factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.

This is afull-time salaried position withProject Farma,a PerkinElmer company. The successful candidate willresidein one of Project Farma’s primary markets and bewilling to travel domesticallyto meet client project requests.

Project Farma’s purpose is toimprove patient lives by acceleratingthe delivery of life-changingtherapies.Weaccomplishthisthrough thesuccessful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) teammemberscollaboratewith cross-functional teams to build trusted client relationships, deliveran exceptionalcustomer experience, andcontributeto business growth byidentifyingopportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.