US-MA-Cambridge: Quality Engineer
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- Collaborate with site Validation and Engineering and Facilities in continuous improvement projects related to these functional areas. Ensure quality is in integrated effectively while maintaining practical controls for both business and compliance needs
- Oversee the change-control aspects of assigned equipment/systems; ensuring validation impact assessment, procedural impact, regulatory impact, and prescribed testing is adequate and well justified.
- Key contributor for engineering and validation studies, reports, and validation plans ensuring compliance, consistency, and adherence to industry standards and practices
- Development and management of performance metrics/KPIs related Quality and Engineering operational activities
- Mentoring and technical development of staff in areas of expertise and relevant experience
- Perform external/internal audits for critical engineering vendors and activities as required.
- Confident in knowledge of validation principles as related to the pharmaceutical environment
- Strong understanding of Change Control Systems as related to equipment, instruments, or software
- A minimum of 6 years of Quality experience in a biotech or pharmaceutical industry preferred.
- Experience with Microsoft Office, Visio, and basic statistics
Education BS degree in Engineering, Chemistry, Microbiology or related field is required.
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Team SQAFYI - Software QA Resource FYI