Pharma Automation & Controls Engineer - Project Farma

The Digital Transformation & Automation (DT&A) Engineer provides subject matter expertise in the design, implementation, and lifecycle management of digital systems across biologics, pharmaceutical, and novel therapy manufacturing facilities. This is a fully billable role, requiring 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. In addition to technical experience, the DT&A Engineer acts as client liaison during delivery of Project Farma service engagements.

Key Responsibilities

Automation 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, including 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), and 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.

Experience Required

• Bachelor's degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related).
• Minimum 2-16+ 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.

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.
• Demonstrated leadership and mentorship abilities.