Validation Engineer/Validation Specialist
A Validation Engineer / Specialist is responsible for performing start-up, commissioning, and validation activities within the scope of work from assigned project. 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 the Project Manager or Lead. Such items may include the following: start-up procedures, commissioning documents, validation protocols and reports (IQ, OQ, CSQ, PQ, process validation, cleaning validation, etc.), development reports, acceptance testing protocols. May also assist in the production of user requirements, specifications, standard operating procedures and other documentation required for the completion of the 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 performing factory acceptance testing and site acceptance testing as assigned by the Project Manager, Project Lead or Senior Validation Specialist / Engineer II. The work may include the preparation or review of the acceptance testing protocol
- Responsible for review of the vendor or contractor documentation as required by the Project Manager, Project Lead or Senior Validation Specialist / Engineer II
- Interact directly with client on an as needed basis regarding system/process specific activities and basic project related activities. Act as liaison between client and Project Leader/ Project Manager as needed
Support TVS internal and infrastructure activities as requested
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, 25 Apr 2017 16:18:36 PDT