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.