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Cleaning Validation Engineer

  1. Cork
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
14-09-2023
32136
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Cleaning Validation Engineer - Pharmaceuticals - Cork - 11-months+ Contract 

One of our global Pharmaceutical clients is looking for a Cleaning 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.

What you will do: 
  • Execute cleaning cycle development and PQ of equipment.
  • Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
  • Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
  • Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
  • Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
  • Technical report writing, statistical analysis of data
  • Adherence to the latest regulatory guidelines.
  • Represent the IPT on cross-functional project teams.
  • Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
  • Adherence to highest standards for Compliance (Quality and Safety)
  • Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
Experience, Knowledge & Skills:
  • 3-5 years’ experience as a validation specialist in a pharmaceutical or a highly regulated environment and a B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field.
  • 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.
  • These include, but are not limited to:  GLIMS and eVAL, electronic batch records.
If this role is of interest to you, please apply now! 

The candidate must have the rights to work in the location stated in the job advert.

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