Role: Our client is a leading pharmaceutical company who are hiring a Cleaning and Sterilisation Validation Engineer to join their team in South Dublin. As the Cleaning and Sterilisation Validation Engineer you will also ensure that the facility is in compliance with the Division Quality System and that international standards are met. This job will mainly cover cleaning and sterilisation activities associated with our client’s vial and syringe manufacturing. In this job you will also be involved in a variety of new product introduction. As the Cleaning and Sterilisation Validation Engineer, your job will additionally involve aiding the combination of the client’s full finish and cleaning facility. You can find more details below to see if this role is right for you.
- Developing a cleaning and sterilisation validation strategies, validation plans, protocols and reports for all relevant equipment and processes for a Sterile Fill Finish Facility.
- Ensuring all aspects of cleaning and sterilisation validation adhere to required policies and procedures, including training and safety.
- Ensuring the site meets quality requirements of its customers and applicable regulations.
- Pre-approve and post-approve vendor protocols and assessments from a quality system documentation perspective.
- Handling biological indicators and performing thermal mapping executions with validation hardware.
- Assisting in the development of existing validation programs to ensure continued compliance.
- Assisting in deviation and exception resolution and root cause analysis.
- 4+ years’ experience in a relevant position.
- Relevant third level qualification.
- GMP experience in pharma/bio.
- 2+ years’ cleaning and sterilisation experience.
- Problem solving ability.
- Excellent communication skills.
- Component preparation commissioning experience advantageous.
If you are interested in getting involved in in the type of role described, apply to Jasper Wiley at Sigmar Recruitment or call Jasper at 01 4744623 for a confidential conversation.
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