Headcount Solutions is seeking a Project Manager for our client’s biotech facility in Dublin. Reporting to the PMO Lead, this person will be responsible for scope development, and execution of operational, capacity, and technical projects supporting various areas within the organization, i.e. Supply Chain, Manufacturing, Quality, and could include Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation, Device Assembly, Inspection, Labelling and Packaging areas.
- Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.
- Candidate will need to be a proactive leader managing daily tasks and owning a program that will have cross-functional projects.
- Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning, and operational readiness; as applicable.
- Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up.
- Development and management of change controls.
- Resolves workstream issues arising throughout the project, manages risk logs, and escalates when appropriate to keep objectives and deliverables on track.
- Work in a collaborative manner within the various operational teams’ structure and contributes to Root Cause Investigations and Cross Functional Investigations.
- Works in a collaborative manner with the Operators, FLMs, System Owners, Maintenance Supervisors, Technicians, Engineers and Vendors to perform equipment upgrade and/or retrofits as well as continuous improvements.
- Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures.
- Provide support with the completion of deliverables as required.
- Day to day management of communication and any other tasks/projects assigned as per manager’s request.
- Provides direction, sets high expectations and measures workstream performance in making the site operationally ready for product transfer to the new line.
- Bachelors’ degree in Engineering or similar relevant qualification.
- Excellent project management skills with the ability to lead effectively in highly matrixed organization.
- At least 8+ years’ experience in a GMP, Biopharmaceutical manufacturing plant industry / aseptic pharmaceutical environment.
- Demonstrated experience in a GDP Compliant environment.
- Experience in MS Office, MS Project, Change Control & Document Management Systems.
- Excellent team development, communication, and interpersonal skills.
For further information please contact Mick on 086-0435195 or forward details in confidence to [email protected]