Biotech Validation Engineer

Biotech Validation Engineer , Dun Laoghaire, Dublin

Office / Project Location : Dun Laoghaire, Dublin

Employment Type : Contract

Work Location :    Site based

Pay :  €55 - €68 per hour

Experience : 5 + years

Visa :  EU passport or Stamp 4 visa required

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 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.

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)

Requirements

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

Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects

Experience of sterile / biotech equipment within the pharmaceutical industry is preferred

Experience of aseptic processing

Experience in GMP

Package

Contract role - Hourly rate €55 - €68 per hour

Minimum 12 month contract with the possibility of an extension.

Onsite Expectations : 5 days per week. Once the projects are at certain stages there will be opportunities throughout to do some hybrid work.

These projects require the Validation Lead to be onsite.

Unfortunately, on this occasion we cannot accommodate someone who is looking to work frequently remote.