Project Engineer

ROLE OVERVIEW

The Senior Project Engineer will lead and support facility modification works within a biologics GMP manufacturing environment, managing the full project lifecycle from scoping and planning through to commissioning, qualification, and handover. This role requires strong technical ownership, vendor management capability, and the ability to coordinate effectively across multidisciplinary teams to deliver projects safely, on time, and within budget.

KEY RESPONSIBILITIES

• Lead and manage facility modification and capital improvement projects from initiation through to close-out
• Develop and manage project scope, schedule, budget, and resourcing plans
• Drive execution of IQ, OQ, and PQ activities, including protocol development, execution, and documentation, ensuring alignment with GMP and regulatory requirements
• Manage vendor and contractor relationships, including scope negotiation, technical clarifications, performance tracking, and issue resolution
• Coordinate cross-functionally with Process, Facilities, Engineering, QA, and Manufacturing teams to ensure project deliverables meet operational and compliance requirements
• Review and develop engineering deliverables including design documents, P&IDs, URS, FDS, and technical specifications
• Identify, assess, and mitigate project risks, proactively resolving technical and schedule-related issues
• Support change control, deviation, and CAPA processes related to project execution
• Prepare and present project status reports, updates, and key milestones to stakeholders and management
• Ensure all project activities comply with site EHS, GMP, and regulatory standards
• Support procurement activities, including preparation of technical bid evaluations and vendor selection
• Drive continuous improvement initiatives across project execution processes

REQUIREMENTS

• Degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related discipline
• Minimum 5 years of project engineering experience within a biologics, pharmaceutical, or GMP-regulated manufacturing environment
• Demonstrated experience managing facility modification or capital projects from planning through to qualification
• Strong hands-on experience with IQ, OQ, and PQ processes, including protocol authoring and execution
• Proven vendor and contractor management experience, including scope management and performance oversight
• Solid understanding of GMP requirements and their application to facility and equipment projects
• Strong project planning and scheduling skills, with the ability to manage multiple concurrent workstreams
• Excellent stakeholder management and cross-functional coordination skills
• Strong problem-solving ability with a proactive approach to risk identification and resolution
• Effective written and verbal communication skills, including experience preparing technical reports and stakeholder updates

PERSONAL ATTRIBUTES

• Strong ownership mindset with the ability to drive projects independently
• Detail-oriented with a strong focus on quality, safety, and compliance
• Resilient and adaptable in a fast-paced, dynamic project environment
• Collaborative team player who works effectively across all levels of the organization