Biopharma Project Lead Engineer – GMP & Compliance

Collins McNicholas Recruitment; Munster; On-site; EUR 70,000 - 95,000; Full time

Job summary

Collins McNicholas Recruitment is seeking an experienced Engineering Project Lead to plan, execute and deliver pharmaceutical engineering initiatives in a fast-paced GMP environment in Ireland's Munster region.

The role covers project scope, schedule, budget, risk management, and cross-functional collaboration with QA, Validation, Manufacturing, EHS, and vendors to ensure timely delivery and regulatory compliance.

Qualifications

• GMP, validation, and pharmaceutical manufacturing environments experience.
• Experience managing multiple engineering projects within regulated industries.
• Proficiency with MS Project or Primavera.
• Strong analytical, leadership, organizational, and problem-solving skills.

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.

Skills

Project management

Leadership

Analytical skills

Organizational skills

Problem-solving

Education

Bachelor's degree in Engineering

Tools

MS Project

Primavera

Job description

Collins McNicholas Recruitment is seeking an experienced Engineering Project Lead to plan, execute and deliver pharmaceutical engineering initiatives in a fast-paced GMP environment in Ireland's Munster region.

The role covers project scope, schedule, budget, risk management, and cross-functional collaboration with QA, Validation, Manufacturing, EHS, and vendors to ensure timely delivery and regulatory compliance.