Are you a Manufacturing Specialist with 5+ years experience in aseptic Drug Product Manufacturing or related cGxP manufacturing experience?

If interested, please forward your CV to karen@jobcontax.com for review or call 353-1-7978720 to discuss in confidence.

Manufacturing Specialist - Aseptic Processes - Biotech - Dublin

Job Description

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 Project Engineer – New Syringe and AVI Lines Operations Readiness will report to the Operational Readiness Programme Lead within the Operations Function. 

They will be responsible for providing project management and engineering support for projects in the Operations Readiness Programme for the new syringe and AVI lines. 

Arrange agreement among the project team, customers, and management on the goals of the project.

Work 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, which 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.

Requirements 

Technical Degree and/or Masters’ or equivalent 

The successful candidate will have five to eight years of experience within the pharmaceutical or biotech industry and will have demonstrated project management skills.

Experience in a project engineering and management role in a pharmaceutical or biotech manufacturing facility engaging with site SMEs and managers along with global functions.

The ability to influence and lead cross functional teams to deliver their projects that ensure a smooth start-up of the new vial filling line.

The ability to work independently and identify risks and mitigation pathways to ensure project deliver

A passion for continuous improvement applied to project management

Experience in a Life Science / Pharmaceutical / Biotechnology Environment

Preferred Experience: Project Engineering & Management, Aseptic Filling Line Operations, MES/EMBR, Validation, Greenfield / Brownfield start up.

Systems / Equipment: 

MS Office, MS Project, MS PowerPoint, and MS Visio, 

Change Control & Document Management Systems

Preferred Requirements: Smartsheet

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 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 EMBR projects

Knowledge or experience with validation of Aseptic Filling Lines

Package

Contract role. €0- €0 Per Hour

Min 12 month contract

Contact

Karen McHugh is the consultant managing this position.

If you are interested in this role you can contact Karen by e-mail at karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Manufacturing Specialist roles in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.