Project Lead Engineer

Project Lead Engineer - Kerry

The Project Lead Engineer is responsible for planning, executing, and delivering key projects that support biopharmaceutical manufacturing, facility upgrades, technology transfers, and process improvements.

This role ensures that projects meet regulatory, safety, quality, and business requirements while coordinating cross functional teams and external vendors.

A Bachelor's Degree in Engineering or related field, or significant experience managing pharmaceutical engineering projects, equipment vendors, and cross functional teams in a GMP regulated environment.

Essential Knowledge & Experience

• Strong knowledge of GMP, validation, and pharmaceutical manufacturing, with proficiency in project management tools (e.g., MS Project, Primavera) and strong analytical, organizational, and troubleshooting skills.
• Excellent leadership, communication, stakeholder management, and people management abilities, with proven capability to manage multiple projects in a fast paced, regulated setting.

Responsibilities

• Project Management: Lead end to end engineering projects, develop scopes, schedules, budgets, risk assessments, and deliver controlled handovers and closeouts while presenting progress to stakeholders.
• Technical Leadership: Provide engineering expertise across equipment, utilities, automation, and process systems; develop URS/design documents; review drawings, FAT/SAT protocols, and support commissioning, qualification, and process optimization.
• Cross Functional & Vendor Coordination: Collaborate with QA, Validation, Manufacturing, Supply Chain, EHS, and external contractors/OEMs; facilitate design reviews, hazard assessments, change controls, and technical meetings.
• Compliance & Quality Assurance: Ensure all deliverables meet GMP/GDP, FDA, EMA, ICH, and internal standards; support IQ/OQ/PQ and FAT/SAT activities; maintain documentation for audits and regulatory needs; promote strong safety culture.
• Budgeting & Cost Control: Prepare capital justifications, manage CAPEX budgets, track expenditures, control change orders, and support procurement, vendor selection, and contract negotiations.
• Risk & Performance Management: Identify and mitigate project risks; maintain documentation and progress tracking tools; evaluate project outcomes to drive continuous improvement.