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.
* 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.
* 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
Certified Global Meeting Planner
Good Manufacturing Practices
Title 21 Of The Code Of Federal Regulations
Coaching And Mentoring