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, c GMP, 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 CQVHandover 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 €3 MExperience in a large company environment Experience in working and communicating globally Experience in pharmaceutical or biotech industry Hands on attitude.
