Computer Systems Validation(CSV) Engineer

Skills

Job Specifications

Job Title- Computer Systems Validation(CSV) Engineer

Work Location: Norwood, Massachusetts (Hybrid)-Open for Relocate

Interview Mode: Video

Visa:- USC, GC, GC-EAD, H4-EAD Only

Duration 12 Months Contract

Job Description:

GxP Systems Engineer who will serve a key role supporting the Validation, Delivery and Administration of the GxP laboratory benchtop computerized systems and Enterprise systems. This role will be a member of the Digital Quality team and requires both strong intellectual agility and hands-on technical skills. Activities will also include authoring and executing test protocols.

Here’s What You’ll Need (Basic Qualifications)

• A bachelor’s degree in STEM or another relevant academic discipline

• A minimum of 4 years’ experience working in a controlled cGxP environment; a combination of education and experience may be considered with an MS degree.

• Experience authoring and reviewing computer system validation lifecycle documents.

• Experience with Document Management, QMS, ServiceNow and System Administration activities.

• Experience authoring and executing validation lifecycle deliverables within an SDLC tool (KNEAT).

• Experience writing change controls and deviations/CAPAs utilizing GxP workflows. Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Experience with Benchtop lab computerized systems like TOC, Bioanalyzers, Spectramax/Softmax etc.

• Experience with Enterprise Instrumentation Systems such as Chromeleon Chromatography Data System, Mettler LabX, etc. is preferred.

• Experience working in life sciences, pharma/biotech, or high-tech industries with a preference for experience in one or more of eCommerce, data/machine learning platforms, or cloud infrastructure.

• Experience in a regulated environment

• Experience working in a matrixed organization. • Experience working in a fast-paced environment requiring quality contribution on multiple critical projects.

• Demonstrated ability to work independently and collaboratively in cross-functional teams and open to learn and adapt to changing demands.

• Strong communication skills (verbal and written)

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

• Experience working with laboratory instrumentation connectivity and data.

• Familiarity with Computer Systems Validation standards and deliverables.

Best Regards,

Jaideep Shastri

916-365-9533 (D) | jaideep.shastri@fustis.com

About the Company

Welcome to Fustis, your trusted partner in connecting IT consultants with clients. With a proven track record of delivering high-quality human resources across diverse job roles, we specialize in maximizing your time and investment. At Fustis, we believe in the transformative power of our people to drive your business forward, leveraging their technical expertise and collaborative spirit to achieve success. As your dedicated liaison between jobs, consultants, and clients, we bridge the gap to ensure seamless operations and m... Know more

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