Minimum 5 years of experience in Computer Systems Validation or Quality in a regulated environment.
Extensive knowledge of GAMP and risk-based validation approaches.
Familiarity with 21 CFR Part 11 and GCP regulations.
Bachelor's degree in life sciences or engineering required.
Experience with validation strategies and data integrity in GCP environments.
Responsibilities
Ensure all computerized systems are validated for tools, products, and studies.
Maintain awareness of data management and validation needs in a GCP environment.
Help project teams define validation strategies and testing approaches.
Review and approve Validation Plans and Reports.
Assist in scoping validation efforts based on corporate risk management.
Review test executions performed by Software Test Analysts during validation activities.
Mentor junior CSV team members and cross-functional teams on validation approaches.
Benefits
Opportunity to work on cutting-edge 4G study deployments.
Engagement in a collaborative environment with cross-functional teams.
Access to ongoing training and development in CSV and GxP compliance.
Involvement in audits as a CSV subject matter expert.
Potential for career advancement within a regulated industry.
Full Job Description
Description
The Sr. Computer Systems Validation Engineer (CSVE) 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. CSVE will also ensure validation and data security of the overall infrastructure for 4G study deployments.
Key Accountabilities of the Sr. CSVE 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.
Mentor junior CSV team member(s) and cross functional teams on CSV to CSA approach.
Guide CSV team member(s) regarding questions on validation approaches and strategies.
Requirements
The position requires a minimum of 5 years of 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 sciences or engineering.
About 4G Clinical
4G Clinical is a software company that provides cloud-based solutions for clinical trials. The company's platform, Prancer, uses natural language processing and machine learning to automate the design, randomization, and supply chain management of clinical trials. Prancer also provides real-time analytics and reporting to help clinical trial sponsors make data-driven decisions. 4G Clinical was founded in 2015 and is headquartered in Medford, Massachusetts.
