Biotech Validation Engineer - Syringe Filling Line - Hybrid
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Site based with Hybrid options
Pay: €60 - €70 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 €60 - €70 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.