- Generation of protocols, summary reports, and protocol exceptions in Kneat
- Scheduling and execution of qualification activities
- Qualification data collection and analysis against acceptance criteria
- Documentation updates (SOPs, Forms, etc.)
- Meeting attendance and project coordination
- Bachelor's degree in engineering or physical science or related field
- Kneat Validation Software User
- CIP/SIP experience for Manufacturing equipment (vessels, piping)
- Temperature mapping experience with wired Thermocouples (Kaye Validator 2000, and AVS) and wireless probes
- 7+ years of experience in aseptic fill manufacturing, specifically the commissioning and qualification including performance qualifications of: Vial Washers, Depyrogenation Tunnels, Isolators, Sterile Fillers and Cappers
- 7+ years of relevant FDA regulated industry experience
- Knowledge of cGMP, good documentation practices and other regulatory standards
- Exceptional technical writing, review and analytical skills
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Sr. Validation Engineer - Los Angeles, United States - VTI Life Sciences
Description
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 an experienced Validation Engineer to support the Aseptic Fill/Finish line qualification project at our client's pharmaceutical facility in the Greater Los Angeles area. We need a seasoned validation engineer who is a self-motivated, self-starter who can be creative when developing documents within our client's guidelines. This individual needs to be able to process instructions and work independently on multiple projects in a fast-paced environment.
RESPONSIBILITIES:
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 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.
