Regulated Manufacturing Project Lead

Collins McNicholas Recruitment & HR Services Group; Connacht; On-site; EUR 90,000 - 130,000; Full time

Job summary

Mayo based client is seeking an experienced Engineering Project Manager to lead cross-functional projects spanning new product development, process improvement, equipment implementation and commercialisation within a highly regulated manufacturing environment.

This role offers the opportunity to take ownership of complex projects, coordinating across Engineering, Operations, Quality and Suppliers while ensuring adherence to regulatory and design control requirements.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 5–8 years' experience in engineering/manufacturing, with at least 3 years' project or programme management experience.
• Experience within a regulated manufacturing environment.
• Experience in process development, equipment qualification and/or manufacturing transfer.
• Experience with automated production equipment and structured problem-solving methodologies.
• Knowledge of Lean, Six Sigma, DOE or statistical analysis is desirable.
• Strong project planning, analytical and organisational skills.
• Excellent communication and stakeholder management skills.
• Experience in medical devices, pharmaceuticals or another FDA/regulatory environment is advantageous.

Responsibilities

• Lead cross-functional project teams from development through to commercialisation.
• Develop and manage project plans, schedules, budgets, resources and timelines.
• Coordinate activities across Engineering, Operations, Quality, Suppliers and other key stakeholders.
• Identify and manage project risks, issues and mitigation plans.
• Lead technical scope definition, equipment implementation and process development activities.
• Coordinate equipment and process qualification, validation and manufacturing transfer.
• Monitor project progress and communicate milestones, risks and outcomes to senior stakeholders.
• Manage supplier relationships and external project partners.
• Support capacity planning, cost reduction and continuous improvement initiatives.
• Ensure projects comply with quality, regulatory and design control requirements.
• Manage multiple projects simultaneously within a complex technical environment.

Skills

Project management

Stakeholder management

Communication

Lean Six Sigma

Statistical analysis

Analytical skills

Organisational skills

Education

Bachelor's degree in Engineering

Tools

Automated production equipment

Job description

Mayo based client is seeking an experienced Engineering Project Manager to lead cross-functional projects spanning new product development, process improvement, equipment implementation and commercialisation within a highly regulated manufacturing environment.

This role offers the opportunity to take ownership of complex projects, coordinating across Engineering, Operations, Quality and Suppliers while ensuring adherence to regulatory and design control requirements.