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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 industry.

We are currently seeking a CSV Engineer for a 2+ month contract to work on a Class 1 Medical Device Packaging Labeling System validation project for our client in the New York Metropolitan area.  This role will be approximately 50% onsite and 50% remote.

Job Responsibilities:

• Author and execute the typical validation Life Cycle documentation, including Validation Plans/Summaries, User

Requirements, Functional/Design Configuration Specifications, Trace Matrix, Risk Assessments, Qualification Protocols (IQ/OQ/PQ) and Test Scripts.

• Assist systems users with defining and documenting system use in user, admin, and maintenance SOPs.

• Provide tactical guidance and coaching in support of system testing requirements based on GAMP principles and 21 CFR, Part 11, Annex 11 compliance and ISO 13485.

• Take ownership of related tasks, work under minimal supervision, utilize your industry experience and best judgment to make tactical decisions, stay proactive, etc.

Job Qualifications:

• BS in Science or Engineering is required.

• 5+ years of Biopharmaceutical or Medical Device CSV experience is required.

• Specific hands-on experience with validating BarTender (Medical Device) labeling software is preferred.

• Understanding of Data Integrity and GAMP concepts is required.

• Excellent communication and technical writing skills required.

• Local candidate in the New York City area is preferred.

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. www.validation.org

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