Senior Project Engineer - Capex Projects

Project Engineer / PM

Pharmaceutical & Medical Device Manufacturing · Mayo

The Role

One of our key clients has an opening for a Project Engineer within the Engineering team in Mayo, who design and manage the engineering projects for the site. Duties include new installations and improvements to the existing manufacturing process.

Project Engineers are responsible for executing projects within the framework of cGMP and in compliance with global and local requirements. Within this role, the Engineer will lead and manage multiple projects, consulting with the project team and all associated departments on site and ensuring work is completed to the specified quality, on time and within budget.

Key Responsibilities

■ Work in a safe manner and in compliance with all Health, Safety & Environment mandatory policies, standards and procedures

■ Support and adhere to personnel and manufacturing policies and procedures

■ Adhere to the Change Control Management System for all changes to the existing process or the implementation of new systems

■ Drive change by assessing opportunities, presenting proposals, gaining support from key stakeholders, assembling relevant team members, obtaining finance and managing budgets

■ Write Design Specifications and complete equipment IQ/OQ/PQ activities as part of project execution

■ Perform risk management, translate the results into action and execute the implementation plans

■ Plan and prioritise workload to ensure agreed deadlines are achieved

■ Occasionally perform other engineering duties to support the operation, as management may require

■ Be available to work outside core hours from time to time to ensure project timelines are achieved

■ Take ownership of projects, participating in audits by the various regulatory agencies and presenting to visitors as Subject Matter Expert

■ Work proactively and professionally with internal and external cross-functional team members and third-party service providers

Experience & Qualifications

■ Primary degree in Engineering (or an equivalent combination of training and experience)

■ Minimum 5 years’ experience in pharmaceutical or medical device manufacturing equipment or processes

Desirable

■ Project Management training

■ Minimum 5 years’ experience in a related field

■ Experience in Construction / Facility systems / Utility systems / Pharmaceutical Processing

■ Experience in commissioning