Job Type: Contract
Job ID: JO-2206-30116
Consultant: Karen McHugh
Are you a Project Manager with 8+ years of experience in a GMP, Biopharmaceutical manufacturing plant industry / aseptic pharmaceutical environment?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353-1-7978720 to discuss in confidence.
Project Manager – Biotech - Dublin
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.
Contractors have a history of either extending their contract or being offered permanent positions on this site.
The person in this position will be the supporting the operational areas throughout the site with specific responsibilities in Project Management.
The position will report to the PMO Lead responsible for the Risk & Business Development Department.
The Project Manager reports to the PMO Lead and is 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
Ability to translate strategic/emerging technology solutions into pragmatic executable plans
Development and management of change controls
Participate as a member of multidisciplinary site and multisite teams
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
Support a safe working environment by complying with environmental health/safety practice, rules and regulations
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.
Data driven decision maker & problem solver
Ability to work to tight deadlines in a fast-moving environment
Ability to build working relationships and effective partnerships at all levels in the organization
Excellent oral and written communication, facilitation, organizational and planning skills
Proactive, self-starter with the ability to take on several projects at one time
Provides direction, sets high expectations and measures workstream performance in making the site operationally ready for product transfer to the new line.
Provides clear definition of workstream scope, roles and responsibilities and resolves disputed areas.
Alerts senior management of significant program quality, compliance, and safety risks.
Provides input, innovative solutions and options to the workstreams to maintain solution integrity and meet project timelines.
Communicates effectively with Project Team, Workstream Teams, Site Leadership Team, and others
Ensures adequate workstream team resources are provided to deliver as outlined.
Thinks LEAN and embeds LEAN concepts into program delivery
Routinely reports progress against deliverables and key performance metrics.
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
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
Excellent team development, communication, and interpersonal skills
Demonstrated ability to lead/influence others.
Demonstrated ability to make effective decisions in challenging circumstances.
Demonstrated ability to manage conflict.
Demonstrated ability to identify risk and react appropriately.
Contract role. €60- €70 Per Hour
Karen McHugh is the consultant managing this position.
If you are interested in this role you can contact Karen by e-mail at firstname.lastname@example.org or phone +353-1-7978720 for a confidential chat.
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