What are the responsibilities and job description for the Validation Engineer position at Katalyst CRO?
Responsibilities
- 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.
- 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 .
- Degree qualified - ideally science or engineering.
- Other further education and work experience may be considered.
- Minimum 5-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.
- Excellent written and oral communication skills.
- Ability to work as a team.
- Manage your own time and workload.
- Excellent organizational skills.
