Project Engineer II

Job Title:

Project Engineer II

The Project Engineer II leads capital projects that support equipment installations, modifications, and process improvements in a GMP-regulated pharmaceutical manufacturing environment. This role manages projects from concept through startup and qualification, working cross-functionally to deliver safe, compliant, and effective solutions that support operational and business objectives. The position combines project management, technical ownership, and quality leadership to enhance safety, quality, efficiency, and reliability across manufacturing operations.

• Lead capital projects from initial concept through commissioning, qualification, and operational handover with minimal supervision.
• Define and manage project scope, schedule, budget, and resource requirements to meet agreed objectives.
• Manage vendors, contractors, and procurement activities to ensure successful and timely project delivery.
• Identify and mitigate project risks, proactively driving issue resolution to maintain project timelines and budget.
• Lead design reviews and approve engineering deliverables to ensure alignment with process, safety, and operational requirements.
• Oversee installation, commissioning, startup, and troubleshooting of manufacturing equipment and systems.
• Provide technical guidance on equipment modifications, process optimization, and system improvements to support manufacturing needs.
• Ensure all projects comply with FDA, GMP, and internal quality system requirements throughout the project lifecycle.
• Own change control activities, including initiation, impact assessment, and development of implementation strategies.
• Lead validation and qualification efforts (IQ/OQ/PQ), ensuring systems and equipment are ready for regulatory inspection.
• Ensure all project documentation adheres to ALCOA+ data integrity standards.
• Serve as the primary engineering representative on cross‑functional project teams, aligning Manufacturing, Quality, Validation, Maintenance, and EHS stakeholders.
• Provide clear and timely communication on project status, risks, and mitigation strategies to stakeholders.
• Mentor junior engineers and provide guidance to technicians and operators during project execution and equipment startup.
• Drive continuous process improvements that enhance safety, product quality, and operational efficiency.
• Support site initiatives related to right‑first‑time execution and inspection readiness.
• Identify and implement opportunities for cost savings, capacity increases, and reliability improvements.
• Develop and approve key project documents, including user requirement specifications (URS), functional specifications, protocols, and reports.
• Track and report on project performance metrics such as cost, schedule, and scope, and take corrective actions as needed.
• Lead project closeout activities, including turnover to operations and lessons learned to improve future project execution.
• Collaborate actively across teams, functions, business units, and locations to achieve shared goals and deliver superior service to internal and external customers.
• Demonstrate agility by proactively identifying changes in the environment and leading or embracing change to maintain project and business success.
• Contribute innovative ideas, products, services, or process improvements that introduce new capabilities or significantly enhance existing ones.
• Execute responsibilities with a strong focus on quality, reliability, and operational excellence in alignment with organizational culture and strategy.

• Bachelor’s degree in Engineering, such as Chemical, Mechanical, Biomedical, Industrial, or a related discipline.
• 3–6 years of experience executing capital projects in manufacturing environments.
• 5+ years of experience in a regulated environment or within pharmaceutical or medical device industries.
• Demonstrated experience leading capital projects from concept through commissioning, qualification, and operational handover.
• Proven ability to define and manage project scope, schedule, budget, and resources with minimal supervision.
• Strong project management skills, including risk identification, mitigation, and…