Engineering Validation Consultant
5 days ago
Mason Alexander is seeking a skilled Validation Engineer to join their Quality & Regulatory team on a permanent basis in Wicklow.
This is a fantastic opportunity to work closely with our team, focusing on performing and executing validation and qualification duties for all projects across the site.
Key responsibilities as a Validation Engineer include:
- Development of Installation Qualification and Operations Qualification (IQ and OQ) protocols for all new engineering projects.
- Conducting IQ and OQ qualification/validation tests.
- Presentation of qualification/validation reports to relevant Q.A. for approval.
- Guiding Q.A. personnel on validation requirements for the Engineering Department.
- Participating in the Validation Group Meeting and serving as the point of contact for Validation/Quality issues.
- Verifying documentation written by Engineering Department members to ensure adherence to Validation protocols and Company policies.
- Supporting the Engineering Department on quality/validation issues for specific projects.
- Collaborating with Project Engineers and Q.A. personnel to complete project documentation within defined time frames.
- Maintaining a library for validation documentation/guidelines.
- Managing the Change Control System for the Engineering Department.
- Guaranteeing compliance with GAMP Guidelines and Good Weigh Practice while making policy and decision-making for Calibration and Metrology.
Required qualifications:
- Bachelor's degree in a Scientific/Engineering field.
- At least 4 years of experience in a Validation position within the pharmaceutical, biotech or medical device industry.
This is a hybrid role requiring 3 days per week on site.
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