Senior Validation Engineer
Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical clients is looking for a Senior Validation Engineer to join their team in Dublin for their new large-scale facility.
This is a fantastic opportunity to be part of a fast-paced, €700 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.
This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.
Essential Duties and Responsibilities for this Senior Validation Engineer role include, but are not limited to, the following:
- Developing and maintaining the site Validation Master Plan.
- Driving completion of cleaning and sterilization cycle validation activities.
- Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) and revalidation.
- Develop post OQ documentation.
- Authoring and reviewing standard operating procedures and technical reports.
Experience required as a Senior Validation Engineer:
- Experience with upstream cell culture and/or downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
- Technical operations experience in the drug substance manufacture of biological molecules at the pilot- and/or commercial-scale.
- Prior experience in drug substance , process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
- Temperature Mapping Experience.
- Cleaning Validation Experience.
- Partswasher and Autoclave Experience.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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