Project Manager - Manufacturing Support (Vial & Syringe), Dun Laoghaire, Dublin
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Hybrid, 3 days per week onsite
Pay: €60 - €68 per hour
Experience: 7+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
The Senior Project Manager — Manufacturing Support is responsible for a broad variety of project management activities that support both Direct Manufacturing and Manufacturing Support across vial and syringe drug-product (DP) and finished drug-product (FDP) operations.
The role will help plan, coordinate and deliver New Product Introductions (NPIs), deviation lifecycle development, operational and strategic projects (including capital, reliability and process-improvement / volume initiatives).
Embedded in Manufacturing Support, the post will partner closely with Direct Manufacturing, Process & Aseptic Owners, Quality, Engineering, Validation, MES/, Technical Writing and other site and global stakeholders to establish safe, compliant and sustainable project management that maintain supply continuity.
Support both Direct Manufacturing and Manufacturing Support across ADL's vial and syringe drug-product (DP) and finished drug-product (FDP) operations.
Project manage timelines associated with complex investigations (deviations, aseptic excursions, batch issues, equipment failures) owning timelines, meeting scheduling, communications and lifecycle visualisations / tracking.
Maintain daily/weekly project momentum with clear project controls, ensuring on-site presence and hands-on leadership of cross-functional teams.
Lead and facilitate project meetings and governance forums to accurately capture and track actions, timelines, deliverables, milestones and decision-points; clarify and document roles and responsibilities and ensure timely closure and verification of action owners' commitments.
Provide timely escalation of project risks and issues and make decisions that enable progress within the contract timeline.
Effectively communicate with everyone involved in the project
Have a controlled scope in place, that is understood by all stakeholders maintained throughout completion of the project
Maintains Actions/Risk and Decision logs
Works with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on timeScope of role / key responsibilities
Project planning & delivery
Define and align project objectives with Direct Manufacturing customers and site leadership. Create and maintain comprehensive project plans that address quality, scope, cost, schedule, resources and manufacturing readiness.
Project Manage medium to large technical projects (capital, reliability, NPI, lifecycle) from concept through design reviews, build, validation readiness and handover to operations.
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
Requirements
Technical Degree and/or Masters' or equivalent
5-8 years of experience (including min of 3yrs as Project Manager) in a Life Science / Pharmaceutical / Biotechnology Environment
Portfolio Management, Portfolio Resource Management, Business Case Development
PMP or PRINCE2 certification.
Experience with Lean Six Sigma methodologies.
Knowledge of industry-specific regulations and standards.
Systems / Equipment:
Smartsheet, MS Office, MS Project, MS PowerPoint and MS Visio,
Trackwise Change Control & Document Management Systems
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
Package
Contract role - Hourly rate €60 - €68 per hour
Minimum 12 month contract
Hybrid role 3 days per week onsite