Job Title: Equipment Validation Specialist
This is an exciting opportunity to work as a key member of a biopharmaceutical company in South Dublin.
About the Role:
* Conduct periodic reviews of instrument validation as part of the validation life cycle.
* Alert Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conduct impact assessments/investigations as required.
* Schedule and coordinate equipment repairs and maintenance with vendors/contractors, while minimizing downtime for lab equipment and disruption to laboratory activities.
* Participate in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
* Where applicable, own and project manage change controls and adherence to Change Control metrics.
* Support and manage the addition of project components to CMMA Maximo.
* Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems.
About You:
* Detailed knowledge of the methodology, instrumentation, and analytical techniques used for biopharmaceutical testing.
* Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
* Demonstrated success in managing an equipment qualification or maintenance program is advantageous.
* Applicants interested in contracting opportunities within the pharmaceutical sector in Ireland must have a Stamp 1 G or a Stamp 4 visa.
* Please note that we are unable to provide visa sponsorship.
Benefits:
* Work from home.
About Us:
We are a biopharmaceutical company based in South Dublin. We specialize in secondary manufacturing activities such as formulation, fill finish, and packaging. We are committed to providing high-quality products and services to our customers.