The Validation Engineer will be based within Packaging facilities responsible for ensuring that all validation activities associated with the vial and syringe manufacturing facility follow division quality system requirements and recognised international standards.
Other responsibilities will include;
- Development of the packaging and inspection validation strategy, validation plans, protocols and reports for all equipment and processes, not limited to FATs/SATs, IV/FTs, risk assessments, IOQ’s, PQ’s etc.
- You will ensure all aspects of packaging and inspection validation adhere to required policies and procedures, including safety and training.
- Ensure that the site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. Knowledge of ISO 13485.
- Author and execute protocols, reports and assessments from a quality system documentation perspective for primary and secondary packaging, semi-automatic and automatic vision inspection machines and inline/offline leak tester devices used to support sterile vial and syringe Manufacturing.
- The Validation Engineer will update and maintain responsible Standard Operating Procedures (SOP's) in accordance with site and corporate requirements
- Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. Cross functional investigation team.
- The Validation Engineer will assist in the development of any existing validation program to ensure continued compliance to the necessary regulations. Input to site validation guidance documents.
- Assist in deviation and exception resolution and root cause analysis.
- Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area
The next Validation Engineer should have a third level qualification in Science/Engineering with 4 years’ experience in a similar role. You should have business knowledge with automated Inspection and/or Packaging
Equipment commissioning experience and experience with introduction of New Products (NPI’s) would be an advantage along with Validation lifecycle documentation
If you’re looking to work with a world leading Biotechnology company that offers flexible working get in touch now!
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