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Validation Engineer

Validation Engineer required for a permanent role in Cambridge working for a leading manufacturing organisation.

The main responsibilities of a Validation Engineer will be the development, evaluation and validation of manufacturing processes both at our clients' headquarters and at their clients primarily in the pharmaceutical and medical sectors.
Key Skills:
, A degree (2:1 minimum) in a Science/Engineering discipline
, Experience with automated assembly equipment including procurement, set up and validation Experience of building requirements specifications
, Experience of medical process validation DQ, IQ, OQ, PQ and methods such as DOE
, Experience in ISO 14971 - Application of Risk Management to Medical Devices
, Risk Management Files; Plans, Hazard Assessments, Design FMEA, Process FMEA Experience with injection moulding, tooling and machinery
, Working to ISO 13485, ISO15378 and 21CFR820 quality requirements
, Experience in API/Final Product Pharmaceuticals environments
, Conversant in Current GMP and Engineering Guidelines
, Experienced working in design teams Good knowledge of Design History File
, Documents; Plans, Design Inputs, Verification, Validation, Design Reviews, Design Outputs Change Management, Discrepancy Management, Complaint Handling and CAPA
, Ability to write factual reports in a methodical and timely manner
, Ability to communicate findings to clients at all levels
, Ability to lead projects, taking responsibility for quality, time and profit
, Bright, conscientious and creative with an ability to demonstrate a hobby or interest with a practical or technical relevance