Validation Engineer
- Cork
- Contract
- Commissioning, Qualification and Validation
One of our global pharmaceutical clients is looking for a Validation Engineer to join their team close to the picturesque and historical city of Cork. The site is renowned for manufacturing excellence and plays a vital role in the company's large-scale biotech operations worldwide.
The site has received €130 million in investment over the last five years to continue the growth and expansion of the facility; with new products coming to the site, it is an exciting time to join the team.
Validation Engineer Responsibilities:
- Execute and provide technical support for Building 8 upgrade project during the C&Q phase.
- Execute the validation of equipment, cleaning, utility systems, facilities, processes and/or automation systems for projects and post OQ activities.
- This includes adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
- Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
- Technical report writing, statistical analysis of data
- Support the completion of validation projects through adhering to validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing
- Adherence to the latest regulatory guidelines.
- Apply Lean Six Sigma and Lean methodologies to drive a culture of Continuous Improvement within the IPT.
- Represent the IPT on cross-functional project teams.
- B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering, or a related field.
- 3-5 years’ experience as a validation specialist in a pharmaceutical or a highly regulated environment
- Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
- A working knowledge of the GxP systems associated with this role would be advantageous.
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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Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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