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Validation Project Engineer job in Shrewsbury at Adepto Technical Recruitment Ltd

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Validation Project Engineer at Adepto Technical Recruitment Ltd

Validation Project Engineer

Adepto Technical Recruitment Ltd Shropshire, Shropshire Full-Time
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Validation Project Engineer - Med Device / Pharma - Perm - South Cheshire

Our client is a leading life science organisation specialising in the development and innovation of medical device and pharmaceutical products. At present, they are seeking a Validation Project Engineer on a permanent basis at their site in South Cheshire.

Key Areas:

* Manages major projects; both infrastructure and instrument.

* Ensures the timely and accurate delivery of equipment, to allocated budgets.

* Ensure that all equipment and records meet cGMP requirements.

* Ensure that all activities are performed in full compliance with the requirements of the corporate and appropriate divisional quality manuals.

* Ensure all laboratory, production, warehouse and IT systems are suitably qualified and controlled in accordance with FDA 21 CFR Part 11 and EU GMP Annex 11.

Responsibilities:

* Ensures equipment is successfully validated ready for use by all laboratories for when required. - Both Equipment Qualification and Computer Systems Validation

* Responsible for leading the validation activities all operational equipment and infrastructure as appropriate in accordance with FDA 21 CFR Part 11 and EU GMP Annex 11.

* Supports all medical device laboratories and deals with any technical issues concerning qualification of test equipment and instrumentation.

* Perform or oversees equipment / infrastructure projects within agreed budgets and timescales.

* Ensure qualifications are performed accurately and in a timely manner in order to meet customer requirements.

* Produces and maintains high quality, concise and thorough records and reports, for all aspects of the project lifecycle.

* Interpret stakeholder requirements to produce fully define user requirement specifications.

* Participate and cooperate with internal and external quality audits, ensuring that non-conformities are corrected within agreed timeframes.

* To provide technical validation expertise and support in the form of protocol development and execution in the following areas: process validation, cleaning validation, computer systems validation and facility/utility validation.

* Assists the laboratory supervisors to provide training and mentoring to laboratory staff on newly acquired equipment and validation approaches
 

Recommended Skills

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Job ID: 213502385

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