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Validation Engineer
Job Posted: 3 days ago
Salary: £ 47,000/Annum
Job Type: Permanent
Location: Sudbury, Suffolk
Expire in: 24 days
Job Description
Your new company
Working for a leading brand manufacturer, you will be joining their point of care diagnostics team as a Validation Engineer, providing engineering/technical support for manufacturing operations.
Your new role
You will be part of the engineering department driving effective process management, continuous improvement with a key emphasis on providing expertise in all aspects of process, equipment and computer system validation and technical support. You will assist with impact assessments, prepare and validate protocols, review and approve validation, technical documentation and SOPs. You will support in customer audits, regulatory inspections, maintain compliance with data integrity regulations, GAMP standards, 21 CFR Part 11. Working closely with project teams to assist with the selection, installation and commissioning of new equipment and quality systems
What you'll need to succeed
With an engineering background, degree qualified or equivalent, you will have experience gained within medical product manufacturing, be fluent in cGMP principles with a thorough understanding of regulatory requirements for EMA ISO13485 and USCFR 820. Ideally, with an electrical/mechanical/mechatronics background, strong IT skills, and problem-solving/investigation skills.
What you'll get in return
26 + 8 holidays with a holiday buy-back scheme offering an additional 5 days annually, up to 10% employer pension contribution, share and bonus scheme, flexible benefits including private medical and dental cover, employee assistance programme and volunteer days.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
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