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 currently seeking a QC Analytical Instrument Qualification Engineer for a project at our client site in the Greater Boston Area, MA. Responsibilities include the qualification of various Analytical Laboratory Instruments/Software including MALDI TOFs, QPCRs, LCMS , Plate Readers, HIACs, Thermomixers, etc.
Responsibilities:
• Generation of instrument qualification and CSV documents including specifications, protocols, reports, SOPs, and discrepancies.• Protocol execution using instruments and associated software.• Capable of working independently.
Desired Skills and Experience:
• 5+ years of experience in the generation of instrument qualification and CSV documents and protocol execution using instruments and associated software.• Knowledge of USP 1058, 21 CFR Part 11, Annex 11, GAMP 5 and Data Integrity• Knowledge of FDA regulations, and application of cGMP and cGDP.• Understand industry standards related to validation.• Ability to write detailed investigation reports and qualification/validation documents that consistently meet Company and regulatory agency requirements.• Excellent verbal and written communication skills.• Must be able to read, write, and converse in English.• Bachelor's Degree in engineering, science, or related technology fieldVTI 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.
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