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Senior Computer Systems Validation Engineer

4G Clinical

This is a Contract position in Lubbock, TX posted October 8, 2021.

Description In addition to Wellesley, MA, we welcome candidates in Portland, OR, and Raleigh-Durham, NC.

Fast Company recently announced its 2020 Best Workplaces for Innovators list, honoring businesses and organizations that demonstrate a deep commitment to encouraging innovation at all levels.

4G Clinical came in at 8 for its dedication to building a culture that fuels innovation, curiosity and the spirit of experimentation in all facets of the business from product development and brand to services and staffing.

We were also voted one of the 2018 Best Places in Health Care & Biopharma by Great Place to Work® and FORTUNE .

4G Clinical is a global leader in randomization and trial supply management (RTSM) and supply forecasting optimization software for the life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solutions utilizing natural language processing (NLP) to accelerate clinical trials.

4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia Job Requirements: RESPONSIBILITIES The Sr.

CSV Engineer (Sr.

CSV) will ensure all validation activities and deliverables for core products and study-related projects are properly planned and documented and will provide Quality oversight for testing during the overall validation processes.

The Sr.

CSV will also ensure validation and data security of the overall infrastructure for 4G study deployments.

Key Accountabilities of the Sr.

CSV include the following: Ensure all computerized systems are appropriately validated including tools, products and studies.

Maintain awareness of data management, validation, and data integrity needs in a GCP regulated environment.

Help project teams define appropriate computerized systems validation strategies, including testing approaches and identifying appropriate objective evidence.

Assist in identifying and validating internal tools that have a GxP impact.

Review and/or approval of Validation Plans and Reports.

Assist in scoping validation efforts based on a corporate risk management approach.

Review and approve test executions performed by the Software Test Analysts during study validation activities.

Work closely with DevOps to ensure requirements for electronic data security and infrastructure validation is comprehensive and complete.

Participate in audits as a CSV subject matter expert.

Assist in the training of CSV requirements to all areas of 4G.

Assist in the development and maintenance of validation-related procedures and deliverables in Quality.

Evaluate CAPAs to identify areas of improvement for validation.

Report regularly to Quality management on the validation efforts and deliverables.

Assist other departments with tasks as appropriate.

REQUIRED EXPERIENCE The position requires a minimum of 5 years’ experience in Computer Systems Validation or Quality-related position in a regulated environment.

Extensive knowledge of GAMP, risk based approach to validation, and 21 CFR Part 11.

Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, and associated worldwide regulatory guidance documents.

EDUCATION AND/OR CERTIFICATION REQUIREMENTS The candidate must possess a bachelor’s degree in a life science or engineering or similar field.

OTHER SKILLS/REQUIREMENTS Strong technical writing skills with attention to detail.

Excellent communication skills.

Motivated to work in a fast-paced, constantly-changing environment Strong organization, multi-tasking and prioritization skills.

Demonstrable resilience in prioritizing quality and validation against aggressive time constraints Experience with IRT/RTSM and quality system

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