Biopharma Project Lead Engineer - GMP & Process Improvement

DPS Group Global; Munster; On-site; EUR 70,000 - 110,000; Full time

Job summary

DPS Group Global in Kerry seeks a Project Lead Engineer to oversee biopharmaceutical facility upgrades, technology transfers, and process improvements. You will coordinate cross-functional teams and external vendors, ensuring regulatory, safety, and quality standards are met.

The role requires a Bachelor's in Engineering or equivalent experience managing pharmaceutical engineering projects in GMP environments. Strong leadership and project-management skills are essential for success.

Qualifications

• Bachelor’s Degree in Engineering or related field, or significant experience managing pharmaceutical engineering projects in GMP-regulated environment.
• Strong knowledge of GMP, validation, and pharmaceutical manufacturing.

Responsibilities

• Lead end-to-end engineering projects, develop scopes, schedules, budgets, risk assessments, and deliver controlled handovers.
• 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.
• Collaborate with QA, Validation, Manufacturing, Supply Chain, EHS, and external contractors/OEMs; facilitate design reviews, hazard assessments, change controls, and technical meetings.
• 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.
• Prepare capital justifications, manage CAPEX budgets, track expenditures, control change orders, and support procurement, vendor selection, and contract negotiations.
• Identify and mitigate project risks, maintain documentation and progress tracking tools, and evaluate project outcomes to drive continuous improvement.

Skills

Project management

Leadership

Communication

Cross-functional collaboration

GMP knowledge

Problem solving

Education

Bachelor’s Degree in Engineering

Tools

MS Project

Primavera

Job description

DPS Group Global in Kerry seeks a Project Lead Engineer to oversee biopharmaceutical facility upgrades, technology transfers, and process improvements. You will coordinate cross-functional teams and external vendors, ensuring regulatory, safety, and quality standards are met.

The role requires a Bachelor's in Engineering or equivalent experience managing pharmaceutical engineering projects in GMP environments. Strong leadership and project-management skills are essential for success.