Process & Utilities Engineer

Role Summary:

• A fantastic opportunity has arisen for an experienced Project Engineer/Manager with background in delivering end to end projects in pharmaceutical Solid Oral Dose drug product manufacturing applications to join our client’s site based in Co. Wicklow.
• Leads and executes medium and large sized capital projects according to requirements for project management fulfilling all capital, quality, and compliance requirements.
• Area of projects implementation: Pharmaceutical processing equipment and associated utilities.

Core Duties and Responsibilities:

• Uses project management methodologies and skills to manage capital projects of varying complexity across organizational boundaries and is responsible for their successful delivery.
• Ensure projects are conducted at the highest quality, within time and budget, and that the risk level is managed per GMS procedures and stakeholder expectations.
• Coordinate and supervise project execution related activities through the full lifecyale, from initiation to close out (hand-over).
• Lead a cross functional team of internal and external specialists.
• Responsible for meeting project scope requirements, schedule requirements, and costs.
• Ensure compatibility and consistency with existing organization and industry standards (PMM, cGMP, GEP, etc.)
• Coordinates all stakeholders, facilitates problem solving sessions and/or other planning sessions, and makes adjustments in project in alignemnt with overall business strategy.
• Responsible for the adequate utilization of all quality systems as defined by Procedures within the projects organization.
• Ensures appropriate safety measures are taken to prevent injuries and minimize safety risks. Takes a proactive approach to safety.
• Ensures readiness for inspections together with quality organizations.
• Ensures compliance with rules and regulations of procurement and accounting.
• Specific projects to be executed are generally in the Processing area and include:
  • Upgrade to high speed Capsule Filling equipment to accommodate granule handling
  • New product introductions (NPI) in the drug product environment
  • Upgrades to process equipment utilities & associated plant
  • Replacement of fixed IBC lifting equipment
• Knowledge of manufacturing processes and engineering documents, such as equipment layouts, P&IDs, equipment supplier design documentation.
• High experience of executing full project lifecycle from conception through to handover & training
  • Concept & Basic Design
  • Capex applications
  • Procurement
  • Budget / Schedule / Scope management
  • Management of supplier interface / detail design
  • Management of EHS inputs
  • Equipment installation, management of CQV
  • Handover to end user & training

Minimum Qualifications and Experience:

• Bachelor’s degree in engineering, science or other technical field (engineering degree preferred)
• Minimum 10 years experience in running/managing projects/programs through full lifecycle with total costs up to €3M
• Experience in a large company environment
• Experience in working and communicating globally
• Experience in pharmaceutical or biotech industry
• Hands on attitude. Role will involve installation activities on the shop floor
• Management of contractors & suppliers for site works
• Strong financial and business accumen
• High leadership skillset
• High strategic thinking
• High facilitation and presentation skillset
• High stakeholder management skillset
• Knowledge of scheduling and cost estimation/controlling
• Anticipates and resolves conflict situations
• Capability of analyzing and solving complex problems through innovative thought and experience
• Team based player
• High Quality & EHS awareness
• Risk focused
• Certified PM according by IPMA or PMI is a plus

Please note, we do not require agency assistance with this role.