Project Manager

Project Manager

PROCHEM Engineering

Kildare, Ireland

Role Summary:

• The Project Manager is a crucial role within the Project department to ensure the introduction of new equipment and processes and to perform technical development of existing processes.
• Working in a highly regulated and cGMP environment within the pharmaceutical industry the Project Manager will report directly to the Engineering Manager on all aspects of the role including but not limited to; introduction of new projects, troubleshooting issues, equipment upgrade and procurement in the manufacturing/packaging and process validation activities.
• The successful candidate must have strong leadership and planning qualities, be adaptable to change and be comfortable leading cross functional teams delivering to strict deadlines.
• Pharmaceutical projects knowledge and equipment procurement and validation experience is required.

Core Duties and Responsibilities:

• Project management and co-ordination including planning, scheduling, task management and delegation, milestone planning, communication and reporting.
• Delivering projects on time and on budget.
• Leading and Managing projects for projects assigned, equipment and processes to meet all safety, quality, regulatory and operational requirements.
• Ensuring that all HSE aspects are considered through all phases of the project, including design, construction, commissioning through to handover to Operations
• Provide practical safety leadership and promoting and improving everybody’s safety culture
• Developing and implementing of project specific plans, safety training and programs
• Co-coordinating of management of HSE performance
• Leads investigation team on any project related incidents
• Ensure compliance with national legislation.
• Managing and executing process and equipment trials and validation.
• Leading cross functional teams as part of project planning and deployment including collaboration with supporting departments such as Production/Operations, Quality, Safety, Regulatory Affairs, Facilities and Engineering, Supply Chain and Finance, Project scoping and gap analysis.
• Equipment specification/design/procurement/installation and validation.
• Optimisation of existing processes to achieve product output targets.
• Co-ordinating changes using the approved change control procedure to ensure that cGMP is adhered to.
• Generation, review and approval of project documentation (Scope, User Requirement Specifications etc), trial reports and Standard Operating Procedures.
• Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQOQ etc).

Minimum Qualifications and Experience:

• B.Eng in Engineering or appropriate science or engineering discipline.
• A minimum of 5 years’ recent experience in a project management role in the Pharma/Biotech/Chemical industry.
• Pharmaceutical Manufacturing processes understanding and experience e.g. dry blending, compression, compaction, coating, granulation (wet and dry), containment, material handling etc.
• A proven track record in project management.
• The ability to organise, plan and execute multiple tasks to tight schedules
• Experience with leading cross functional teams is desirable.