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Senior Validation Consultant
3 weeks ago
The role of the Senior Validation Engineer at GxP Recruitment is to cover validation activities within the wider project, encompassing the testing and manufacture of a new medical device.
Key Responsibilities:
- Develop and approve validation documentation, including protocols, records, and reports.
- Oversee process and test method validation activities within the project.
- Execute process and test method validation activities in association with Operations, Quality Assurance, and R&D teams.
- Evaluate validation activities for timely completion and adherence to the project plan.
- Ensure compliance with current Good Manufacturing Practices (GMPs) and 21 CFR 820 requirements in all validation aspects.
- Collaborate with functional groups to ensure awareness of validation requirements.
- Analyze and troubleshoot validation problems that may occur, determining solutions.
- Communicate validation results and progress to management.
- Prepare summaries of validation testing for regulatory submissions, presenting validations to regulatory agencies as required.
Required Qualifications & Experience:
- Bachelor's degree in an engineering, technology, or scientific discipline, with 5+ years' experience in the medical device or pharmaceutical industry.
- Prior experience in designing and executing process and test method validations.
- Strong analytical skills, exceptional writing, and interpersonal relationship skills, or a combination of relevant work experience and education.
- Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements.
- Able to work efficiently as part of a team, meeting targets and goals.
- Demonstrated organizational, management, and communication skills.
- Good interpersonal and communication skills essential.
