Validation Specialist

Job Title: Validation Specialist
Contract Type: Permanent
Location: Radlett, Hertfordshire
Salary: Negotiable
Start Date: ASAP
Reference: J895552_1529308692
Contact Name: Danny Speed
Contact Email:
Job Published: June 18, 2018 08:58

Job Description

Validation Specialist - Sterilisation

Type: Permanent

Location: Hertfordshire/ Bedfordshire

Our Client - a leading Pharmaceutical company are looking to appoint an experienced Validation Specialist to work at their prestigious site; the successful candidate will be given the chance to work with some of the best technologies and will be offered further career scope in the growing validation/ process improvement team.

Reports to Validation Manager

The Role:

  • Ensuring compliance with all applicable (EHS and GxP) regu latory and internal QMS standards and industry best practice.
  • Highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle; so that they are understood/ transparent and can be managed through the application of a quality risk management approach.
  • You need to be committed to, and passionate about providing a reliable and compliant service to meet and exceed the customer's needs. This is a customer-facing role, and as such the ability to form relationships across the organisation is essential for success.
  • Collective responsibility for the ongoing compliance of all assets at the different sites within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
  • Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.
  • Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.

Essential Skills :

  • Must have worked within a in Sterilisation Validation (SIP)
  • In depth knowledge of the requirements of EN285 and its practical application when validating porous load sterilisers.
  • In depth knowledge of the requirements and expectations associated with depyrogenation validation.
  • In depth knowledge of the requirements and expectations associated with Hydrogen Peroxide bio decontamination.
  • Fully conversant in the requirement and expectations around cycle/load development and worst case challenging of sterilisation/depyrogenation/bio decontamination processes.
  • Practical hands-on experience of executing sterilisation/depyrogenation/bio decontamination validations.
  • You understand, can clearly explain and would be able to train others sterilisation/depyrogenation/bio decontamination validation.

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k

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