Senior Validation Engineer

Desired Skills: validation,fill finish,GMP

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 responsible for ensuring that the Validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are in compliance with GMP and Quality Requirements.

Role Responsibilities:

• Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IV’s), Functional Testing (FT’s), Site Acceptance Testing (SAT) and Performance Qualifications (PQ’s) associated with a Syringe Filling Line.
• Pre-Approve and Post-Approve validation protocols.
• Input into site Validation Master Plans and Standard Operating Procedures (SOP’s)
• Collate and Report on relevant validation data/metrics.
• Assist in exceptions and deviation resolution and root cause analysis.
• Reviews Validation planning documents detailing overall strategy for the project.
• Reviews and Approves Qualification summary reports (QSR)
• Generates Validation Summary reports.
• Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)

Skills required:

• 6+ years experience in Engineering or Validation
• Technical qualification at third level or equivalent in Engineering.
• Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects
• Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
• Knowledge of safety and GMP requirements.
• Demonstrated strong Communication skills
• Experience using Paperless Qualification Systems is preferred.
• Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry

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***