Job Details
Job Ref: 213094226
Date: 2021-01-28 15:05:50
We are one of the world’s leading names in Biotechnology and are pioneers in Diabetes, Oncology, Infectious Disease and Vaccines and our research has helped millions of people across the globe.
We are looking to recruit a Validation Engineer to join us on an initial 6 month contract.
You will be responsible for providing project validation support including conducting equipment performance qualifications (specifically cleaning and sterilization validation), authoring project validation master plans; SOP and documentation updates, authoring validation protocols and final reports, executing validation studies, analysis of validation data; Resolving technical issues encountered during study execution.
A minimum of 12 months experience in validation of processes / equipment / utilities / cleaning equipment ideally gained within Biotech or Pharmaceuticals is essential.
Key responsibilities include:
* Execute requalification of equipment, facilities and utilities and periodic review activities in accordance with the Validation Master Plan schedule
* Practical support during protocol execution where required and appropriate.
* Supervise validation testing performed by contractors to ensure work is accurately completed to the required standards
* Assists in developing programs and maintaining standard operating procedures (SOPs)
* Facilitation of the review and approval of validation documents.
* Lead and perform small to medium size validation activities by writing, reviewing, approving and executing documentation for new and current validation activities. This will include the validation of a new parts washer and the temperature mapping and cleaning validation of modified pipework.
* Generating validation technical reports related to systems, products and/or processes, in compliance with company standards and regulatory requirements.
* Review proposed Change Controls (low to mid complex changes) to assess the impact on the validated status and determine the validation strategy as required.
* Provision of advice and guidance on validation related topics and best practices.
* Communicate cross functionally regarding status of validation status and project timelines
* Identification and implementation of continuous improvement initiatives to ensure lean ways of working
Please press apply now to submit your application. Alternatively, if you would like further information on this position or other positions win a similar sector, please feel free to contact our Shaunna Doherty on (phone number removed) for a confidential conversation.
We are an equal opportunities Business. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
Each company within the Planet Equity Group is a “data controller”. This means that we are responsible for deciding how we hold and use personal information about you in line with GDPR guidelines. Full details regarding how we hold your data is available within our Privacy Notice accessible at our website
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