Validation Engineer

Conceives, plans and executes manufacturing process validations plans and studies.
· Adhere to the Change Control and Design Control requirements.
· To create robust validation documents such as Master Validation Plans / Report, IQ, OQ, & PQ's
· Being the lead on the writing and execution of IQ/OQ/PQ protocols.
· RCH/PCH - Routing in MAP Agile & follow up till release
· Updating Control Plan (CP), Assembly Procedure (AP) & Traveler document (TD)
· Preparing protocol & executing Test Method validation (TMV)
· Validation experience using risk-based approach guidelines, international regulatory requirements, and standards
Quality and Compliance Related Responsibilities
· Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations
· Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.


Education
· Degree qualified – ideally science or engineering
· Other further education and work experience may be considered

Experience

• Minimum 3-years' experience of working on manufacturing engineering validation activities
• Some previous experience in medical device or related regulated industry
• Experience in project management and project leadership
• Extensive experience in the preparation of technical documents
• Proficient in PLM tools & Microsoft Office

Personal Attributes

• Excellent written and oral communication skills
• Attention to detail
• Ability to work as a team
• Manage your own time and workload
• Excellent organizational skills