Senior Validation Engineer

Desired Skills: validation,engineering,clean utilities

Description:

PE Global is currently recruiting for a Senior Validation Engineer on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.

Overview:

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

Ensure the clean utilities Validation activities associated with a large fill finish project are

completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Responsibilities:

• Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
• Generation, review and approval of Validation Plans, FAT, SAT IV/FTs, QRAES, PQs associated with clean utility systems (WFI, Clean Steam, Process Air etc.)
• Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.
• Liaise with Engineering, Commissioning and Qualification, manufacturing, planning and PD and external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests to ensure the quality by design principles are being followed.
• Input into site change controls.
• Reviews and Approves all C&Q summary reports and Validation Summary reports.
• Pre-Approval and Post approval of Validation test documents.

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.
• 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 Clean Utility Systems.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@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***