DT&A - Lead Engineer, PLC/DCS

Responsibilities

The Automation Engineer provides subject matter expertise in the design, implementation, and lifecycle management of automation systems across biologics, pharmaceutical, and novel therapy manufacturing facilities. This role requires deep experience with DCS/PLC/BMS/EMS platforms and the ability to author, interpret, and lead documentation such as URS, FRS, Functional Narratives, and detailed system architecture designs.

Automation Design & Architecture

• Develop full automation system architectures for biologics, pharmaceutical, and advanced therapy manufacturing facilities (DCS, PLC/SCADA, MES, historians, network layers, field instrumentation).
• Create ISA-88/ISA-95-aligned architecture diagrams, I/O strategies, network topologies, and interface specifications.
• 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 automation design documents.

Automation Implementation

• Configure, program, and deploy DCS/PLC (modules, phases, recipes, batch strategies, graphics, alarms).
• Support integration of OEM skids: bioreactors, chromatography systems, filtration skids, CIP/SIP, and fill finish equipment, HVAC, Chillers, Boilers, etc.

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 automation changes meet data integrity requirements, change control processes, and validation lifecycle rules.
• Lead deviation investigations, CAPAs, and risk assessments related to automation systems.

Manufacturing & Operations Support

• Serve as SME for troubleshooting, system optimization, alarm tuning, batch failure analysis, and performance enhancements.
• Support 24/7 operations through structured root cause analysis and resolution of automation issues.
• Develop long-term automation lifecycle plans for upgrades, patches, and system expansions.

Cross Functional Leadership - Functional Leadership

• Collaborate with IT/OT, process engineering, quality, and capital project teams to deliver integrated automation 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 mission above ego
• Collaboration & Communication: Communicates clearly and proactively and drives transparent alignment with clients
• Project Execution: Delivers reliably, manages priorities, and drives for high-quality outcomes
• Growth Mindset: Shows openness to new ideas, feedback, and change

Experience Required

• 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/OpEx project management and/or comparable military experience.)
• Strong understanding of ISA-88 batch control, ISA-95 manufacturing hierarchy, BACnet, ISO 16484, and GAMP 5.
• PLC/DCS: 4+ years / 7+ years in automation engineering within GMP life sciences (biotech, pharma, ATMP). Expert-level experience with DeltaV DCS and/or Rockwell/Allen Bradley PLC/SCADA platforms.
• BMS/EMS: 4+ years / 7+ years in building automation engineering within GMP life sciences (biotech, pharma, ATMP). Expert-level experience with common BMS and EMS platforms (Siemens Desigo CC, Rockwell PLC, Schneider Electric, etc).
• Willingness to travel as required for client project assignments.

Other Preferred

• 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.
• Ability to manage scope and track project changes.
• Demonstrated leadership and mentorship abilities.