Automation Project Engineer

PM Group are seeking an experienced Automation Project Engineer to lead the delivery of automation projects within a regulated manufacturing environment. This role is responsible for managing automation workstreams from concept through implementation, ensuring projects are delivered safely, on schedule, within budget, and in compliance with applicable quality and regulatory standards.

The successful candidate will work closely with internal stakeholders, engineering teams, and third-party vendors to deliver upgrades and modifications to a wide variety of site automation and control systems.

Key Responsibilities

• Manage the end-to-end delivery of automation projects, including both regulated (GxP) and non-regulated systems.
• Develop project concepts, automation scope, budgets, schedules, and cost estimates.
• Prepare Automation/User Requirements Specifications (URS) in collaboration with system owners and project stakeholders.
• Lead the automation elements of projects from design through commissioning, qualification, and handover.
• Coordinate and manage external system integrators, vendors, contractors, and internal project teams throughout the project lifecycle.
• Oversee automation development activities, Factory Acceptance Testing (FAT), installation, commissioning, Site Acceptance Testing (SAT), and User Acceptance Testing (UAT).
• Manage project timelines, milestones, risks, deliverables, and automation budgets.
• Support change control processes and ensure all project activities are completed in accordance with site procedures.
• Coordinate with IT teams where infrastructure support is required, including virtual servers, networking, and related automation infrastructure.
• Review, execute, and approve lifecycle and validation documentation, including Functional Design Specifications (FDS), Requirements Traceability Matrix (RTM), FAT, SAT, Installation and Operational Qualification (IQ/OQ), and associated project documentation.
• Act as the subject matter expert for automation standards, validation requirements, hardware, software, and automation lifecycle processes.
• Ensure projects comply with GMP, data integrity, and applicable regulatory requirements.

This role focuses on managing automation vendors delivering modifications to a broad range of site systems rather than supporting a single platform. Projects may involve systems such as:

• Building Management Systems (BMS)
• Process control systems
• DeltaV Distributed Control Systems (DCS)
• Water for Injection (WFI) systems
• Heat pumps and utility systems
• Environmental monitoring and freezers
• Fire detection systems
• Site access control systems
• Sterility testing equipment
• Other manufacturing and facility automation systems

Experience across several of these technologies is desirable; expertise in every system is not required

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Automation, or a related technical discipline.
• Minimum of 5 years' experience delivering automation projects within a GMP-regulated manufacturing environment.
• Demonstrated experience managing automation projects, vendors, budgets, and schedules.
• Strong understanding of cGMP requirements, computer system validation, SDLC methodologies, and change management.
• Knowledge of data integrity principles and electronic systems compliance.
• Excellent project management, stakeholder management, communication, and problem-solving skills.
• Ability to coordinate multidisciplinary teams and multiple concurrent projects.