Validation Lead

PE Global is recruiting for a Validation Lead for a leading multinational biotech client based in Dublin. This is an initial 12-month contract, fully onsite 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.

Key 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, or alternatively send an up to date CV to paul.wheatley@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***