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Validation Specialist

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Validation Specialist

Runcorn, Cheshire

Up to £50,000 dependant on experience

8:00am-5:00pm (Mon-Thursday) 8:00AM – 2:00pm (Friday)

Manage, plan and execute adherence to the Validation Master Plan which includes Process Validation, Equipment Validation, Cleaning Validation and validation of Utilities. Lead, author and perform Installation, Operational and Performance Qualifications.

Key Responsibilities and Duties

Lead validation projects and complete all associated project documentation in line with regulatory expectations.
Manage, coordinate and guide the execution of the site validation master plan.
Provide the relevant support for regulatory audits, submissions and other auditor requests.
 (this requires gaining an in-depth knowledge of the product/system to be able to determine what the necessary output is and if it is meeting predefined criteria).
Ensure projects are managed in conjunction with all regulatory requirements such as health & safety and cGMP.
Ensure changes being made are done so compliantly and in line with regulatory requirements for validation and qualification of equipment, systems, processes and cleaning.
Develop and write commissioning, qualification and validation documents following established standards and templates.
Perform and conduct P&ID walk-downs and verification of system drawings.
Ensure the validation status of equipment and systems are in compliance with cGMPs at all times.
Manage validation documentation, commissioning test scripts, qualification validation protocols, summary reports and risk assessments.
Review design deliverables from engineering including drawings, datasheets, specifications and engineering lists.
Maintain validation documentation through the validation lifecycle.
Maintain validation spreadsheets / trackers.
Perform periodic reviews for processes, equipment and utilities.
Troubleshoot in the event of abnormal testing results.
Ensure accurate records of all validation activities.
Ensure compliance with environment, health and safety rules, signage and instructions.
Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
Any other duties as required by the validation manager to fulfil the needs of the business.

Skills, Experience, and education required

Minimum degree level qualification in relevant life science or equivalent .
Good knowledge of current GMP requirements for validation in the EU
CVS experience (Desirable)

My client is a growing manufacturer who are looking for Experienced, passionate, manufacturing professionals to go on this exciting journey!

FoodH

The UK has now left the European Union. Any EU, EEA or Swiss citizens living in the UK that wish to remain in the UK post Brexit need to apply to the EU Settlement Scheme. Although the closing date for applications was 30th Jun 2021, if you have not yet applied but believe that you would qualify under the EU Settlement Scheme, the Home Office have confirmed that they will consider late applications. For further information please see https://(url removed)/browse/visas-immigration/eu-eea-swiss

Many Thanks

Apply now