Equipment Engineer

Desired Skills: Engineering Projects,Equipment Engineering,Project Management,Drug Product Manufacturing,Change Controls,GMP,Cleanrooms

Overview:

The role is responsible for assisting with the Engineering elements of the expansion project through design, implementation, and operational readiness in collaboration with multiple stakeholder groups.

Note: There will be some travel to the FATs sporadically (July, October and then there’s April and June next year) This will happen as we get the equipment hitting the floor. We will need the person to be onsite five days a week from March till the equipment is validated and tested.

Key Responsibilities:

• As a member of the Engineering team, support the expansion of the existing manufacturing facility, focusing on filling, inspection, and formulation equipment.
• Support the manufacturing readiness strategy, startup, and validation of new systems and equipment to ensure requirements are in line with company standards and fit for purpose.
• Assist with equipment project deliverables of setup, calibration, spare parts management, functional testing, and start-up support.
• Ensure consistency in equipment design and practices, with a focus on simplifying processes and tasks.
• Collaborate with diverse groups including Manufacturing, Quality, PD, Automation, IS, EHSS, and Global Engineering to ensure project delivery.
• Establish maintenance strategies and develop initial PM programs for process equipment.
• Travel as required to support project execution.

Basic Qualifications/Experience:

• Minimum of a Bachelor’s Degree in Engineering (Mechanical, Electrical, or Chemical) with typically 4+ years of experience in engineering projects and systems.
• Fundamental knowledge of applicable quality management and regulatory requirements.
• Solid leadership, technical writing, and communication/presentation skills.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Experience in developing strategies for new product introduction and new technology deployment.
• Team player who actively promotes a culture of clear communication, collaboration, and engagement at all relevant levels for effective decision-making.
• Manufacturing experience in a biopharmaceutical formulation/fill/finish facility.
• Strong technical ability to understand and resolve complex problems as part of a focused and high-performing team.
• Experience in vendor management and contract negotiations with a focus on equipment suppliers.
• Independent, self-motivated, organized, and able to multi-task in project environments.

This role offers an exciting opportunity to contribute to a significant expansion project, working with a dynamic team to achieve operational readiness and excellence.

Additional information:

• Looking for someone who understand manufacturing in a fill inspection formulation equipment. So what we do here is, build the syringes, do the inspections on them and then we do the formulation beforehand.
• Key that the individual know a clean room environment and they’re used to projects in a manufacturing environment where they can get ready to do the calibration, the maintenance, the setup, and the functional testing. 
• Good GMP skills, project skills from that focus of this stage of a project from initial setup to handover.
• Used to dealing with quality and automation and PD from a change control and completing tasks that way. 

Please click the link below to apply or alternatively send an up-to-date CV to howie.leahy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***