- Support and review Quality validation in the review of the Analytical Method Transfer (AMT) documents.
- Review of Commission and Qualification C&Q documents, support the review of lifecycle documentation, including but not limited to system/risk assessments, URS, specifications, etc.
- Review and route for approval validation documents, and the Test Scripts required for assigned projects.
- Support clients in generating and routing for approval of incidents/defects, as a result of test script execution.
- Support clients and system owners in the incidents/defects resolution and corrective actions.
- Use KNEAT software to digitize and manage the CQVprocess
- Bachelor's degree in engineering or physical science or related field
- 5+ years experience in a cGMP pharmaceutical/biotechnology laboratory
- Strong working knowledge of analytical instruments/software and quality assurance validation and method transfer principles
- Be experienced and proficient with the KNEAT software system
- Proficient use of Microsoft Office suite of applications (Outlook, Excel, Word, PowerPoint, Teams, etc.)
- Ability to work as part of a team and also independently with minimal to no supervision
- Ability to rapidly change focus during times of shifting or changing priorities
- Impeccable technical writing skills with extreme attention to detail
- Excellent organizational, multitasking, and communication skills
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QA Validation Engineer - California, United States - VTI Life Sciences
Description
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.We are looking for a Quality Assurance Validation Engineer to support the test method transfer/validation for a variety of analytical test methods at our client's pharmaceutical facility in the Greater Los Angeles area.
RESPONSIBILITIES:
SALARY RANGE FOR THIS ROLE IS $80,000 - $120,000 ANNUALLY FOR A W2 EMPLOYEE
VTI Life Sciencesstrives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries.VTIoffers professional development, training, competitive compensation, excellent benefits, a matching 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
As one of the leading global Commissioning, Qualification and Validation Services organizations,VTIis always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees.
