Lead Automation Engineer, MES & Digital Systems - Project Farma

Responsibilities

• Develop system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing facilities.
• Develop product recipe strategies across the full application layer of ERP, MES and DCS Batch.
• Create ISA-88/ISA-95-aligned architecture diagrams, including Application and Data Flow diagrams.
• Ensure architecture supports scalability, cybersecurity, data integrity, and multi-product flexibility.
• 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.
• Configure, program, and deploy Digital Systems 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.
• 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; review design packages and ensure alignment with internal standards.
• 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.

Qualifications

• 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.

Skills

• Expertise in MES platforms, Data Repositories, and serialization.
• Knowledge of ISA-88 and ISA-95 standards.
• Experience with biologics and sterile/aseptic manufacturing environments.
• Ability to manage complex projects and meet deadlines.
• Strong communication and collaboration skills.

Benefits

• Full-time, salaried position with Project Farma, a PerkinElmer company.
• Opportunity to work in multiple locations including Raleigh, North Carolina, Albany, New York, Annapolis, Maryland, Austin, Texas, Boston, Massachusetts, Columbus, Ohio, Denver, Colorado, Harrisburg, Pennsylvania, Indianapolis, Indiana, and Jefferson City, Missouri.
• Flexible working arrangements, including remote work options.
• Competitive salary range based on experience and qualifications.
• Company commitment to diversity and inclusion.
• Health insurance, retirement plans, and other benefits.

Pay

• Annual compensation range based on experience and qualifications.

Schedule

• Full-time position with flexible working arrangements.