Validation Engineer jobs in Fairfield, CA

• Develop, and optimize the validation strategies for equipment, facility & utility systems, and computerized systems.
• Leverage risk management principles to drive risk-based validation testing and decision-making.
• Author Project Plans, Protocols, and Summary reports; and maintain compliance with new PQS Documents (i.e. Quality Requirement and Global Standard and Processes) for Validation.
• Review Validation Protocols, Commissioning Plans, analyze test results and review summary reports.
• Represent the department on project teams and coordinates activities of Engineering Sciences and Technology, Manufacturing, Quality, and other Vacaville groups required to manage projects.
• Ensure validation documentation is consistent with industry regulations and standards when supporting projects as a contractor.
• Participate in the efforts to evaluate gaps, develop remediation plans, and drive remediation through the Planned/Unplanned Events system for development and deployment of new Roche PQS Documents (i.e. Quality Requirement and Global Standard and Processes) for Validation.
• Provid e technical assessments and validation review of Automation Functional Requirements, Control Qualification testing (recipes, I/O, control module, etc.), P&IDs, engineering changes, and associated start-up documentation; in addition to validation review for engineering, process, and standard operating procedure changes
• Promotes good interdepartmental relations.

• Bachelor's degree (Life Science, Engineering, Biology, Biochemistry) or equivalent validation/GMP job experience.

• 9 or more 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.

• Has advanced knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations, and industry trends.
• Strong technical writing, verbal communication, interpersonal and problem-solving skills.

About the Company:
TalentBurst, Inc.

TalentBurst is an award winning IT and Accounting & Finance staffing firm headquartered in Boston with branch offices in San Francisco, Miami, Milwaukee, Toronto, Bangalore, and Gurgaon. Our clients include the leading social media, technology, banks, utilities, pharmaceutical, and biotech companies.

We work with 75 of the Fortune 500 companies and work on 2,000 new job requisitions per month. Our recruiting team is one of the most successful in the industry. We have a strong reputation for treating our employees well and helping you find your next dream employer. Benefits At TalentBurst, one of our founding principles has been to provide our employees with the best benefits available. To adhere to this principle, we have a broad benefits offering. Our recruiters are dedicated to connecting you with awesome career growth opportunities with leading companies.

Company Size:
5,000 to 9,999 employees

Industry:
Staffing/Employment Agencies

Founded:
2002

Website:
http://www.talentburst.com/