This is a 12 month contract with a view to extension
An amazing opportunity has arisen for a Permitting / Co-ordinator Engineer, at our new state of the art Biotech facility in Meath.
This is a contingent position which will support the start-up activities and programs required for the operational readiness plan for manufacturing at the new BioNX facility. The successful Engineer will work closely with the ORP Handover transition Lead and a team of design and build engineers to transition from project to sustain for all manufacturing assets and processes.
This is a critical role that is mainly responsible for the co-ordination of the PQ (Performance Qualification) activities of the BioNX project and will also include organising & managing resources required during the PQ stage of the project.
• Oversee the site Permit to Work program ensuring compliance with local and corporate regulations
• Act as the site Permit to Work Champion
• Organise external contractors as they come to site to execute PQ activities per schedule details.
• Manage & supervise contractors though the Permit to Work system while carrying out project activities on site.
• Manage and control the site Permit to Work inventory, incl RAMS reviews and approvals.
• Deliver Permit to Work process training to site-based personnel and contingents
• Manage Vendor training on the high hazard Permit areas e.g. Confined Space Entry, EHS Device Bypass, Energised Electrical Work, Excavation and Trenching, Hot Works, Lifting Operations, Line Breaking, LOTO/COHE, Mobile Crane, Working at Height etc.
• Develop and execute an auditing process for the program incl. contractor evaluations.
• Coach site users on best practice
• Network with other Irish site equivalents to share best-practice ideas
• Ensure documentation associated with the Permit to Work system, e.g. SOP, forms and checklists, are periodically reviewed and updated when required.
• Hold and attend team meetings to manage the schedule deliverables
• Develop and maintain an up-to date detailed plan in Microsoft project from workshop updates and Project team/site updates to deliver required team(s) milestones and the critical PQ activities to meet the project milestones
• Use visualisation tools i.e Power-Bi to support stakeholder updates on progress.
• Work with the project planners to integrate the PQ schedule into the critical path schedule
• Manage & supervise contractors though the Permit to Work system while carrying out project activities on site.
• Facilitate daily/Weekly whiteboards to manage daily activities
• Bachelor of Science in Science, Engineering or equivalent.
• Experience within either Biopharma, Pharmaceutical or Medical Device Industries
• Experience required in a leadership role with a multi-national organisation.
• Biologics drug substance manufacturing experience is desired.
• Permitting experience with eg one look system or similar electronic system.
• PQ experience with HVAC, Clean utilities, CTU’s BSC’s, containment labs, & Gases (N2, CO2 etc).
• Microsoft project scheduling experience – min 2 years
• Contractor management skill – past record for organising contractors work on site, permitting, safety management, supervision and sign off permits on site. (PSCS/PSDP past experience a plus)
• Safe pass training.
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Apply For This JobTo apply for this job email your details to helen.halpin@theaphexgroup.com.
To apply for this job email your details to helen.halpin@theaphexgroup.com.