Validation Engineer/Validation Specialist (Lab/Analytical Equipment)
Validation Engineer / Specialist is a full-time, professional position, responsible for performing start-up, commissioning, and validation activities within the scope of work for an assigned project, with an emphasis on computerized laboratory instrumentation and equipment used in GMP, GLP, and GCP environments. An Engineer / Specialist may work as a technical lead on small/medium projects depending on the areas of expertise.
- Responsible for preparing, executing, and/or reviewing validation deliverables as assigned by a Project Manager or Project Lead. Such items may include (but is not limited to) the following: user requirements, functional requirements, impact assessments, risk assessments, factory test documents, start-up procedures, commissioning documents, qualification/validation protocols/reports (IQ, OQ, PQ, software validation, process validation, cleaning validation, sterilization validation, etc.), standard operating procedures, and other documentation required for the completion of system commissioning, qualification, and validation.
- Responsible for providing technical support and technical expertise to project team to facilitate resolution of system and quality issues, either from direct experience or from available source materials.
- Responsible for review of vendor or contractor documentation and test results, as applicable.
- Responsible for direct interaction with client representatives regarding system/process/project specific activities. May function as a liaison between client and Project Leader/ Project Manager, as required.
- Support TVS project team and internal company activities, as required.
- Education or equivalent experience with computerized system life cycle approaches; laboratory equipment and/or analytical instrument commissioning, qualification, and validation; as well as GxP quality systems is expected for this position.
TVS was founded in 1992 and is based in Orinda, CA. TVS is a privately held, medium-sized commissioning/qualification/validation services provider to clients in the greater San Francisco Bay Area (and throughout the West Coast), with significant experience managing and staffing large-scale commissioning, qualification and validation projects. TVS's ability to staff large projects is based upon the efficient management of a significant, highly skilled and flexible internal resource pool.
TVS can support projects, large and small, at various levels, from design review to project completion, managing and/or supporting commissioning, validation and compliance functions. Our current staff includes personnel with biotechnology, pharmaceutical, diagnostic, and medical device experience. We have performed commissioning, qualification and validation services for several large biotechnology and pharmaceutical companies throughout the west coast as well as internationally in Asia and Europe. Our current and past commissioning and validation projects range in size from single pieces of equipment to complete manufacturing facilities.
TVS offer a comprehensive benefits package for it's full time employees including Health, Dental, and Life insurance, 401K contributions, performance based bonus programs as well as paid time off.
Tue, 20 Jun 2017 11:49:11 PDT