- Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and corporate principles, quality policies, standards, and core values. You will work closely with instrument vendors, facilities, IT and lab personnel to coordinate the, 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 company 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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Validation Engineer III
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US_Validation Engineer III
2 weeks ago
Apollo Professional Solutions Vacaville, United StatesJob Description · Validation Engineer · Location: Vacaville, CA · Hourly rate: $ $81.00 · Contractor benefits: Medical, Vision, Dental, 401k · Description: · •Primarily responsible for the support and execution of laboratory equipment qualification and associated computer syste ...
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Clinch Hercules, United StatesBio-Rad is seeking an experienced Quality Engineer to join the Northern California Quality Assurance team to support post market surveillance activities, CAPA and complaint investigations, risk management file creation & updates and support of new product development. · The Qual ...
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Electronic Arts Sacramento, United StatesJoin us for an opportunity to work with the best game development teams in the world. We are looking for a Software Engineer to join the tools development and automation team supporting BioWare, Motive, Cliffhanger, Maxis, Full Circle and Mobile. · This Software Engineer role in ...
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Field Service Engineer III
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KPI Solutions Inc Sacramento, United StatesThe Field Service Engineer III interacts directly with the customer at its place of business to develop the methods and processes best suited to meet the requirements of integrating Intelligrated products into the customer's operations. The Sr. Customer Service Engineer provides ...
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construction building inspector
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4LEAF, Inc Vacaville, CA, United States Full time4LEAF) is a professional services firm specializing in providing Construction Management, Inspection, Plan Review, Planning, and Environmental Services to municipal Building and Public Works Departments throughout the United States. · 4LEAF is seeking highly qualified full-time ...
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Building Inspector III
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4LEAF, Inc Vacaville, United StatesJob Description · Description: · 4LEAF, Inc. (4LEAF) is a professional services firm specializing in providing Construction Management, Inspection, Plan Review, Planning, and Environmental Services to municipal Building and Public Works Departments throughout the United States. ...
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Building Inspector III
2 days ago
4LEAF, Inc Vacaville, CA, United States Full time: 4LEAF, Inc. (4LEAF) is a professional services firm specializing in providing Construction Management, Inspection, Plan Review, Planning, and Environmental Services to municipal Building and Public Works Departments throughout the United States. · 4LEAF is seeking highly qua ...
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Electrical and Power Project Engineer III
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Tesco Controls Inc Sacramento, United StatesJob Description · Job DescriptionDescription: We understand some people are really looking for a stable company where you can grow professionally. For others it's more important to be where you can feel you're helping the environment and community you live in, while at a place yo ...
US_Validation Engineer III - Vacaville, United States - Apollo Professional Solutions
Description
Job DescriptionValidation Engineer
Location:
Vacaville, CA
Hourly rate:
$ $81.00
Contractor benefits:
Medical, Vision, Dental, 401k
Description:
Education:
Meet Your Recruiter
Erica Price
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