Project Lead Engineer

Responsible for planning, executing, and delivering engineering projects supporting biopharmaceutical manufacturing operations, facility upgrades, technology transfers, and process improvement initiatives. Ensures projects meet safety, quality, regulatory, budget, and schedule requirements.

Key Responsibilities

• Lead end-to-end engineering projects including scope, schedule, budget, risk management, reporting, and project handover.

• Provide technical expertise across equipment, utilities, automation, and process systems.

• Develop and review URS documentation, engineering designs, drawings, and FAT/SAT protocols.

• Coordinate with QA, Validation, Manufacturing, Supply Chain, EHS, contractors, and vendors.

• Support design reviews, hazard assessments, commissioning, qualification, and change control activities.

• Ensure compliance with GMP/GDP standards and regulatory requirements including FDA, EMA, and ICH guidelines.

• Manage CAPEX budgets, procurement activities, vendor engagement, and cost tracking.

• Identify project risks, maintain project documentation, and drive continuous improvement initiatives.

Required Qualifications

• Strong knowledge of GMP, validation, and pharmaceutical manufacturing environments.

• Experience managing multiple engineering projects within regulated industries.

• Proficiency with project management tools such as MS Project or Primavera.

• Strong analytical, leadership, organisational, and problem-solving skills.

Preferred Qualifications

• Bachelor’s degree in Engineering or equivalent relevant experience.

• Experience managing pharmaceutical engineering projects, equipment vendors, and cross-functional teams.

Work Environment

• Fast-paced, cross-functional manufacturing and engineering environment focused on compliance, operational excellence, and continuous improvement.

For a confidential discussion and more information on the role, please contact Kevin Griffin. (021) 2427108