Description:
PE Global is currently recruiting for a Validation Lead on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.
Overview
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.
Responsibilities
* 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)
Education / Experience
* 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
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on or alternatively send an up to date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Skills
validation aseptic sterilization
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