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Computer Systems Validation Specialist

Location: Columbus Salary: Negotiable
Sector: Engineering, Embedded Software , Test and Verification Type: Contract

All parties with permanent work authorization in the US are encouraged to apply.

Are you a high energy individual that has extensive experience in medical device industry? Are you interested in working at a leading clinical diagnostics company? If you answered "Yes" to these questions, I have the perfect opportunity for you!

My client, a large bio-science company whose known for providing sophisticated diagnostic systems to doctor's offices, hospitals, and reference laboratories, is actively searching for a Computer Systems Validation Specialist to join its team in Columbus, Ohio. This will be structured as a 6 month contract to hire and pay is $45-$50 per hour.

This medical device company has a leading global workforce of more than 84,000 employees in over 370 locations across 160+ countries. They are looking for a Computer Systems Validation Specialist that will develop, review, and conduct activities related to the validation of automated systems and manufacturing, quality system, and production instruments/equipment. This individual will be involved with all regulated systems and processes throughout the product life cycle including planning, requirements, specification, design, test, install, and verification to establish and ensure compliance.

Among others, this role will take on the following responsibilities:

  • Ensure that Computer Systems Validation deliverables and lifecycle processes are complaint with the Computer Systems Validation Policies and Procedures.
  • Detect actual or potential conditions that could impact the quality, specifically any deficiencies and system incompatibilities. Assure timely and effective preventative action by identifying root causes and non-conformances.
  • Establishing and maintaining a Software Change Control and issue management for regulated Computer Systems.
  • Providing guidance to Supplier Quality when needed in evaluation of software suppliers. Reviewing and approving all non-product software life cycle deliverables from compliance perspective.
  • Supporting other quality system processes, such as CAPA, investigations, internal and external audits, non-conforming material, risk management, process validation, design transfer and training, and several others.

The best candidates for this role will possess the following basic qualifications:

  • B.S. or higher in Software Engineering, Information Management, or Computer Science
  • 5+ years of experience as Software Quality Engineer within a regulated industry
  • Knowledge of ISO 13485, 21 CFR 820, 21 CFR Part 11 and Annex 11 is a big plus

The Computer Systems Validation Specialist is an outstanding opportunity to take on immediate leadership and grow within a top notch organization, and Columbus, OH is a fantastic location!

If you are interested in learning more and/or applying, please reach out to me on the details below!

Sthree US is acting as an Employment Business in relation to this vacancy.