Job Category: Project Manager

Job Description:

The External Supply Device team based in Dublin, has a requirement for a Project Manager to support projects in readiness for launch of high-volume supply of autoinjectors to the commercial market.

Key Responsibilities:

• Understand the scope of work for each project as defined by the Director for Device Supply
• Develop project charters aligned with scope of project
• Establish resources required for successful execution of projects
• Develop and manage project plans with clear objectives and milestone dates
• Engage with internal and external stakeholders for successful execution of projects
• Establish and maintain dashboards / scoreboards for each project to manage and communicate status
• Apply lean methodologies in execution of projects and apply a lesson learned approach in the interest of continuous improvement
• Defining and implementing an appropriate SKU strategy
• Ensuring device specification requirements are met during manufacturing, storage, handling and transport
• Implement an injection molding tooling maintenance and replacement strategy
• Identify and implement improvements for volume scale up projects
• Ensure suppliers meet receiving sites requirements
• Streamlined procurement, manufacture, supply and payment processes

Qualifications and Experience:

• Bachelor’s Degree in a Science, Engineering or Supply Chain discipline
• Project management experience in pharmaceutical operations
• Experience in medical devices with specific understanding of MDR’s
• Knowledge and experience in application of continuous improvement, operational excellence methodologies such as lean six sigma

Ascend PM are hiring a Program Project Manager to join our clients team, a pharmaceutical company based in West Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to clairebrogan@ascendpm.ie to find out more

Overview

The Program Project Manager is responsible for providing comprehensive project and support function scheduling and project management support to the Manufacturing Facility. The program/ project manager must ensure that project objectives and milestones are effectively achieved and consistent with requirements to ensure compliance, safety and efficient project execution.

Roles and Responsibilities

• Development and maintenance of an integrated project schedule to include Engineering, Operations, Quality and Project activities, highlighting key milestones.
• FDA Audit readiness
• Capital Project Program
• Continuous Improvement Projects
• 5 year strategic projects including enterprise production schedule, site development plan
• Establish and effectively manage information management systems, develop reports, presentations, project updates, schedules and timeline updates and correspondence utilizing many different computerized systems.
• Use standard systems including MS Word, MS Project, Excel, PowerPoint and industry/ company specific software for project management, document tracking, reporting, etc.
• Maintain overall program schedule, review and communicate detailed critical path schedules.
• Ensure co-ordination of detailed schedules highlighting resource and deliverables loading.
• Provide effective administrative support to facilitate efficient project management. This may include tasks such as analyzing and reviewing data and compiling summary documents.
• Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
• Be a document system expert; this will include document review, approval and document system work flow expedition.
• Support divisional activities through documentation generation, filing, tracking, auditing and maintenance of associated databases.

Experience, Qualifications and Education Requirements

• Degree / diploma level qualification in Project Management or Engineering plus 10 years’ experience in the Pharmaceutical industry or a similar operating environment.
• Experience with dealing with plant leadership level stakeholders
• Scheduling systems: Primavera, MS Project planning experience.
• Technical cGMP pharmaceutical knowledge and experience of project execution logic.
• Proven application of various planning methodologies used on Facility Construction and Process Equipment development and integration projects.
• Experience of working in professional service company.
• Experience in planning activities within the confines of stringent EHS processes.
• Experience of operating within a Computerized Maintenance Management System (CMMS).
• Experience in the application of lean principles and structured problem-solving techniques.
• Demonstrated ability to identify improvement initiatives.
• An ability to work independently and as part of a team. The successful candidate will be able to organise their own work on a routine basis and requires minimal supervision.
• Experience in working in cross-functional teams.

Ascend PM are hiring a Senior Project Manager to join our clients team, a multinational biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Initially 12 Month Contract with view to extend. Contact or email CV to clairebrogan@ascendpm.ie to find out more.

Overview:

The Senior Project Manager will lead project teams and interact across functional and site department groups to achieve project objectives. These capital projects could include new builds, facilities/utilities system and/or equipment lifecycle replacements, upgrades, manufacturing improvements and changes to support New Product Introductions. The candidate will lead all aspects of their project(s): Safety, planning, cost, schedule, risk, communications, resources, team dynamics and performance, implementation, monitoring, completion and follow-up.

Key Responsibilities:

• Project management and delivery of projects including project planning/scoping and execution, prioritization, resources management, status management and external communication through the Engineering Project Delivery Process.
• Working with various stakeholders, to scope projects and ensure requirements are satisfied. Managing expectations and communicating project progress and challenges to these stakeholders.
• Develop and/or review engineering technical specifications and bid documents for engineered equipment, materials engineering, and construction service contracts
• Lead day to day design (where applicable) and construction management of project works, including procurement, installation, and commissioning
• Provide engineering support for manufacturing processes and equipment within the manufacturing facility by designing, specifying, purchasing and constructing mechanical systems and components (with the aid of an A&E firm where required).
• Implement and maintain quality control processes to ensure that installations and deliverables meet industry standards and client expectations.
• Strategic solution seeking to complex project phasing and execution issues. The Project Manager will be responsible for their portfolio of projects from concept, through design, construction, commissioning and operation
• Coordinating the introduction of new equipment including driving the project team problem solving and troubleshooting process prior to qualification & start-up
• Leader of multidisciplinary site teams
• Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
• Role model safety leadership. Support a safe working environment by driving compliance with environmental health/safety practice, rules and regulations. Ensure projects are designed with superior levels of environmental control, health and safety built in.
• Supervise contingent workers as needed. These workers include construction managers and all general craft labour and A&E firm personnel
• Support team members in the management of third party contractors and outsourced partners to ensure the optimal delivery of portfolio against safety, cost, quality and schedule objectives
• Works with Project Controls to manage and report on the Capital Budget for the assigned project.
• Present projects to senior leadership at governing bodies for updates and approvals
• Limited travel may be required to support execution of projects

Experience and Qualification:

• Bachelor’s Degree in Engineering or Relevant Experience
• Typically, 5+ years project management/engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment
• Proven project management experience from project inception through to handover
• Strong technical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
• Demonstrated experience in a GDP Compliant environment.
• Proven ability working cross functionally, delivering technical solutions and implementing improvements.
• Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results
• Technical report writing and communication/presentation skills
• Data driven decision maker
• Ability to work to tight deadlines in a fast-moving environment