- Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations
- You will work closely with instrument vendors, facilities, IT and lab personnel to coordinate the installation and the qualification including computer system validation, of QC Equipment Reader.
- Perform qualification of laboratory equipment in accordance with EQ policies, plans and procedures.
- Coordinate with laboratory personnel to define qualification requirements.
- Author, review and execute equipment qualification protocols.
- Coordinate equipment qualification activities with vendors and other support groups.
- Coordinate equipment maintenance activities with vendors and other support groups, as required.
- Identify business, quality, and compliance gaps and propose and implement potential improvements to systems and procedures
- Sign documents for activities as authorized and described by the company's policies, procedures and job descriptions.
- Provide input to technical / investigation reports.
- Identify, troubleshoot, and propose resolution to technical problems.
- Receive and provide training.
- Provide input to and participate in assay transfer/validation associated with equipment qualification/lifecycle.
- Coordinate with customers to support multi-site operational activities.
- Present equipment lifecycle and associated procedures/material during internal and external audits and regulatory inspections.
- Works to meet schedules and set timelines.
- Perform other duties as requested by managers to support Quality activities.
- Bachelors degree (Life Science, Engineering)
- Three to six years of validation experience (or equivalent experience) in a cGMP environment with increasing levels of responsibility for a wide range of validation projects including validation of large scale biochemical manufacturing, utility and automation systems.
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6009 Validation Engineer lll
3 weeks ago
Harvest Technical Services, Inc. Vacaville, United StatesJob Description · Job DescriptionOnsite: Vacaville, CA · Job Duties: · Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations · and the companys cor ...
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6009 Validation Engineer lll
1 week ago
Harvest Technical Services Vacaville, United StatesOnsite: Vacaville, CA · Job Duties: · Primarily responsible for the support and execution of laboratory equipment qualification and · associated computer system validation activities in compliance with current cGMP regulations · and the company's corporate principles, quality po ...
6009 Validation Engineer lll - Vacaville, United States - Harvest Technical Services
Description
Onsite: Vacaville, CA
Job Duties:
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.