Junior Process Validation Engineer

Key Responsibilities 

• New equipment specification, sourcing and validation
• Process / product validation
• Concept drawings
• Technical drawing
• Process fault finding and support
• Manufacturing Process Record creation
• Work instruction generation and training
• Technical support
• Technical report generation
• Project management
• Training
• Preparation of auditable records of all activities, such as protocols, lab book records, manufacturing paperwork (R&D and Production), Design History Files

Essential skills:

• Excellent communication skills
• Ability to work effectively with all global cultures
• Pursue expert knowledge of Healthcare regulatory systems
• A passion for continual earning of technical and creative skills
• Commercial awareness
• Relevant IT skills, including CAD
• A high degree of technical knowledge balanced and a hands-on approach
• Programme and project coordination

Essential experience:

• Must have experience in the medical device field with process development, test methods development, protocol and report writing, design verification and experience presenting technical concepts.
• Must have demonstrated capabilities in developing, writing, and executing design validation protocols and reports.
• Demonstrated application of statistical methodologies.
• Experience in Medical Devices and working within FDA/ISO Quality System Requirements.
• Would consider different Engineering disciplines (mechanical, chemical, biomedical) for the position.

Essential qualifications:

Technical/Scientific Degree level qualification in life science subject, or other related fields

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