Automation Engineer

Position Title

Automation Engineer – Capital Projects & Manufacturing Systems

Position Summary

The Automation Engineer will play a critical role in the execution of a major pharmaceutical capital project, providing automation and controls leadership throughout the design, build, commissioning, qualification, and operational readiness phases. The primary focus of this role is supporting Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Commissioning & Qualification (C&Q), and startup activities for new manufacturing lines and process equipment.

The successful candidate will serve as the automation subject matter expert (SME) for process control systems, ensuring equipment is designed, tested, installed, and qualified in accordance with project requirements, GMP regulations, and operational expectations. This role will partner closely with Engineering, Manufacturing, Quality, Validation, Facilities, and equipment vendors to deliver a fully operational manufacturing facility.

Key Responsibilities

Capital Project Execution

• Support the automation lifecycle for large-scale pharmaceutical manufacturing capital projects from design through startup.
• Review and provide input to User Requirements Specifications (URS), Functional Design Specifications (FDS), Software Design Specifications (SDS), and automation architecture documents.
• Collaborate with EPC firms, system integrators, equipment vendors, and internal stakeholders to ensure project deliverables meet business and regulatory requirements.
• Monitor project schedules, deliverables, and automation-related milestones.

Factory Acceptance Testing (FAT)

• Lead or support FAT activities for process equipment, packaging systems, utility systems, and integrated automation platforms.
• Develop and execute FAT protocols with equipment vendors and system integrators.
• Verify automation functionality, alarms, control strategies, interfaces, and system performance against approved specifications.
• Document punch-list items and ensure timely resolution before equipment shipment.
• Evaluate PLC, SCADA, HMI, recipe management, and data historian functionality during FAT execution.

Site Acceptance Testing (SAT)

• Coordinate and execute SAT activities following equipment installation.
• Verify proper installation, network connectivity, instrument functionality, and automation system integration.
• Ensure FAT observations have been resolved prior to SAT completion.
• Support troubleshooting of automation, instrumentation, and controls issues during startup and commissioning activities.
• Drive closure of SAT deviations and punch-list items.

Commissioning, Qualification & Validation Support

• Support Commissioning and Qualification (C&Q) activities for GMP manufacturing systems.
• Review and execute commissioning protocols, IQ/OQ testing, and automation verification activities.
• Partner with Validation and Quality teams to ensure compliance with GMP and data integrity requirements.
• Support Computer System Validation (CSV) activities in accordance with company and regulatory requirements.
• Ensure automation deliverables support successful qualification and regulatory inspection readiness.

Manufacturing Systems & Operational Readiness

• Provide automation support during startup and operational readiness activities.
• Support process engineering and manufacturing teams during engineering, PPQ, and commercial production runs.
• Perform troubleshooting and root cause investigations related to automation and control systems.
• Analyze equipment performance, alarm histories, and process trends to improve system reliability and performance.
• Support handover from project execution to site operations.

Automation Systems Support

• Serve as SME for manufacturing control systems including:
• Distributed Control Systems (DCS)
• PLC-based control platforms
• SCADA systems
• Human Machine Interfaces (HMI)
• Batch execution systems
• Historian systems (OSI PI or equivalent)
• Manufacturing execution system (MES) interfaces
• Review and troubleshoot automation code, control logic, communication networks, and system integrations.
• Support change implementation and lifecycle management of automation assets.

Compliance & Quality

• Initiate and support Change Controls throughout project execution and operational startup.
• Support investigations, CAPAs, deviations, and non-conformance resolution.
• Ensure automation systems comply with GMP, GAMP 5, 21 CFR Part 11, Annex 11, and company quality standards.
• Participate in regulatory inspections, audits, and client visits as the Automation SME.

Cross-Functional Leadership

• Represent Automation Engineering in project team meetings, design reviews, risk assessments, and stakeholder discussions.
• Collaborate with Manufacturing, Quality, Validation, Engineering, Facilities, and external vendors.
• Provide technical mentorship and training to operations and maintenance personnel.
• Support development and review of SOPs, work instructions, and maintenance documentation.

Required Qualifications

• Bachelor's degree in Electrical Engineering, Automation Engineering, Chemical Engineering, Computer Engineering, or related technical discipline.
• 5 years of automation experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.
• Experience supporting major capital projects, facility startups, or manufacturing line installations.
• Hands-on experience executing FAT and SAT activities.
• Strong understanding of PLC, DCS, SCADA, HMI, and industrial control systems.
• Experience supporting commissioning, qualification, and validation activities.
• Knowledge of GMP manufacturing requirements and regulated environments.
• Strong troubleshooting, communication, and stakeholder management skills.

Preferred Qualifications

• Experience supporting greenfield or brownfield pharmaceutical facility builds.
• Experience with DeltaV, Rockwell Automation, Siemens, PCS7, or similar automation platforms.
• Experience with OSI PI, Historian systems, MES integration, or electronic batch records.
• Knowledge of GAMP5, 21 CFR Part 11, Data Integrity, and Computer System Validation.
• Previous experience supporting sterile, biologics, vaccine, cell therapy, gene therapy, or API manufacturing facilities.
• PMP or project management experience preferred.

Key Deliverables

• Successful execution of FAT and SAT for manufacturing equipment and utility systems.
• On-time startup and operational readiness of new manufacturing lines.
• Support completion of C&Q milestones and validation deliverables.
• Reliable integration of automation platforms with manufacturing operations.
• Regulatory inspection-ready automation systems.
• Safe and compliant transition from project phase to commercial manufacturing operations.

Typical Equipment & Systems

• Bioreactors and Fermentation Systems
• Buffer & Media Preparation Systems
• CIP/SIP Systems
• Fill-Finish Equipment
• Packaging Lines
• Purified Water & WFI Systems
• Clean Utilities
• HVAC/BMS Systems
• DeltaV DCS
• Rockwell PLCs
• Siemens PLCs
• SCADA/MES Platforms
• OSI PI Historians