Fill Finish Validation Lead - Dublin

Are you a Fill Finish Validation Lead with 7+ years experience of sterile / biotech equipment validation within the pharmaceutical industries?

This is a contract role based in Dun Laoghaire, Dublin.

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, 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.

Validation lead for a large-scale Fill Finish Project in the Pharmaceutical Industry. 

Lead a team of Validation engineers to ensure the Validation activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements. 

Coordinates and Supervises all Validation activities

Approves Validation planning documents detailing overall strategy for the project.

Develops and approves the master list of Validation test documents and activities.

Reviews and Approves all C&Q summary reports and Validation Summary reports.

Ensures the Validation schedule is developed and maintained.

Ensures all Validation Engineers who perform Validation activities have relevant training assigned.

Pre-Approval and Post approval of Validation test documents.

Manages Validation coordination meetings.

Responsible for Overall Tracking and Reporting of Validation status and risks/issues.

Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)

Requirements

BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality

Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects

Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.

Demonstrated strong Communication and Leadership skills.

Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.

Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry 

In-depth understanding and application of validation principles, concepts, practices, and standards.

In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing

Working knowledge of sterilization/decontamination systems and industry practices.

Experience with AVS (Airflow Visualization) Studies.

Experience of aseptic processing

Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects

Experience of sterile / biotech equipment within the pharmaceutical industry is preferred

Experience in GMP

Package

Contract role - Hourly rate €55 - €65 per hour

Minimum 12 month contract with the possibility of an extension. 

Onsite Expectations: 5 days per week. 

These projects require the Validation Lead to be onsite, once the projects are at certain stages there will be opportunities throughout to do some hybrid work. 

Contact

Karen McHugh is the consultant managing this position.

If you area Fill Finish Validation Lead interested in roles based in Dublin , you can contact Karen by e-mail at karen@jobcontax.com Karen or phone 353 1 7979720 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 Fill Finish Validation Leads in Dublin and Ireland.

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

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