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 € * - €**Apply
on the website** per hour
Minimum * 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.
We need : English (Good)
Type: Permanent
Payment: EUR 55 - 65 Per Hour
Category: Construction
