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Senior validation specialist

Dublin
beBeeValidation
Validation specialist
Posted: 28 August
Offer description

Validation Engineer Opportunity

We are seeking a skilled Validation Engineer to join our team. This is an excellent opportunity to contribute to the development of a world-class manufacturing operation.

The successful candidate will be responsible for ensuring that validation activities associated with a Syringe Filling Line are in compliance with GMP and Quality Requirements.

1. Generation, execution, review and approval of CQV test documentation (FAT, IVs, FTs, SAT, and PQs) associated with a Syringe Filling Line.
2. Pre-approve and post-approve validation protocols.
3. Input into site validation master plans and standard operating procedures (SOPs).
4. Collate and report on relevant validation data/metrics.
5. Assist in exceptions and deviation resolution and root cause analysis.

Key Responsibilities:

* 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 (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).


Requirements

To be successful in this role, you will need:

* 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


Benefits

This is an exciting opportunity to join a leading pharmaceutical company and contribute to the development of high-quality medicines.

You will have the chance to work in a dynamic environment and develop your skills in a world-class manufacturing operation.

In addition, you will benefit from:

* A competitive salary package
* Ongoing training and development opportunities
* A collaborative and supportive work environment

This is a fantastic opportunity to take your career to the next level and make a real difference in the lives of patients around the world.

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