VTI Life Sciences Sr. Computer Validation Manager in San Francisco Bay Area, California
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.
We are looking for a senior-level (8+ yrs) CSV Engineer to establish a CSV Program for our client in the SF Bay Area. Will Manage and Lead project to maintain CSV Program (policies and procedures) based on GAMP 5 (including risk management), GMPs, 21 CFR Part 11, EU Annex 11, and MHRA Data Integrity Guidelines and Regulations. Has the ability to manage several CSV projects, to author documents and collaborate with cross-functional team including Validation, QC, Clinical, QA, IT and Facilities.
Bachelor's degree in science, engineering or technology related field.
8+ years direct experience in Computer System Validation in a cGMP manufacturing environment.
Ability to manage several CSV projects, to author documents and collaborate with cross-functional team including Validation, QC, Clinical, QA, IT and Facilities..
Knowledge of GMPs, GAMP 5, 21 CFR Part 11, Annex 11, MHRA/FDA Data Integrity. .
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics, Medical Devices and Life Sciences industries. We offer professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors. www.validation.org