Purpose
The Project Manager - New Syringe Fill Plant Engineering Readiness will report to the Associate Director. They will be responsible for managing projects within the Operations Readiness Programme for the new fill plant project.
Responsibilities
* Lead and drive Engineering readiness for new filling plant.
* Arrange agreement among the project team, customers, and management on the goals of the project
* Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up
* Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits.
* Development and implementation of maintenance programs and spare parts inventory optimisation with the introduction of new equipment.
* Works with workstream leads to develop and maintain the Project schedule/plan that aligns with the overall goals of the Programme.
* Effectively communicate with everyone involved in the project
* Have a controlled scope in place, that is understood by all stakeholders and maintained throughout completion of the project
* Execute prudent risk and issue management.
* Maintains Actions/Risk and Decision logs
* Generates and owns the GMP change control.
* Motivate, support and direct project team members to deliver on project plan.
* Leads Team meetings and cross functional collaboration
* Works with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time
Compliance Related Tasks:
* Always ensure compliance to cGMP
* Ensure safety & compliance standards are maintained to the highest standards
* Ensure financial compliance in line with Business & Financial guidance
* Support a culture of personal responsibility within reporting structure
Qualifications and Experience
* Technical Degree and/or Masters' or equivalent in Engineering
* 5-8 years of experience (including min of 2yrs as Project Manager) in a Life Science / Pharmaceutical / Biotechnology Environment
* Preferred Experience: Portfolio Management, Portfolio Resource Management, Business Case Development
Skills & Knowledge
* High Energy and Commitment
* Ability to work independently
* Comfortable leading across multiple stakeholders & multinational teams
* Strong ability to influence and affect change
* Capable of resolving issues of conflict effectively
* Strong communicator
* A proven track record in the ability to transfer goals and objectives into measurable plans
* Ability to identify gaps/risks and put appropriate remediation plans in place
* Uses strong relationships to identify requirements and potential opportunities
* Employs project management techniques and Problem Solving
* Provides leadership, guidance, and advice in own field of project management
* Knowledge or experience with MES and MBR projects
* Knowledge or experience with validation of Aseptic Filling Lines
Systems / Equipment:
* MS Office, MS Project, MS PowerPoint and MS Visio,
* Change Control & Document Management Systems
* Preferred Requirements: Smartsheet