Job Title: Validation Engineer
Description: We are seeking a highly skilled professional to ensure that validation activities associated with a Syringe Filling Line for a Sterile fill finish facility comply with GMP and Quality Requirements.
Main Responsibilities:
* Generation, execution, review and approval of CQV test documentation (FAT, IV's, FT's, SAT and PQ's) associated with a Syringe Filling Line.
* Pre-approve and post-approve validation protocols.
* Contribute to 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.
* Review validation planning documents detailing overall strategy for the project.
* Review and approve qualification summary reports (QSR).
* Generate validation summary reports.
* Support 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.
Benefits:
* Hourly rate €60 - €80 per hour.
* Minimum 12 month contract with the possibility of an extension.
* Hybrid work arrangements may be possible at the outset.