Senior Computer Systems Validation Engineer

4G Clinical, LLC; Wellesley (MA); Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health benefits (medical, dental, and

401(k)

Paid sabbatical program

Job summary

4G Clinical, LLC in Wellesley, MA is seeking a Senior Computer Systems Validation Engineer to lead validation efforts for core products and study projects. You will ensure validation plans, testing approaches, and documentation meet GAMP and regulatory requirements, while overseeing data security and infrastructure validation across study deployments.

The role requires 5+ years in CSV or quality roles within regulated environments and a bachelor’s degree in life sciences or engineering.

Qualifications

• 5+ years of experience in Computer Systems Validation or quality-related roles in a regulated environment.
• Extensive knowledge of GAMP, risk-based validation approaches, and 21 CFR Part 11; familiarity with GCP and ICH GCP guidance.

Responsibilities

• Plan and document validation activities and deliverables for core products and study-related projects.
• Provide quality oversight for testing during validation processes.
• Review and approve validation plans and reports; mentor junior CSV staff.
• Collaborate with DevOps to ensure electronic data security and infrastructure validation.
• Participate in audits as a CSV SME and aid cross-functional CSV training.

Skills

GAMP knowledge

GxP understanding

21 CFR Part 11

Quality/regulatory experience

Leadership/mentorship

Education

Bachelor's degree in life sciences or engineering

Job 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.

Summary

4G Clinical is honored to be part of Fast Company's 2020 Best Workplaces for Innovators list, citing 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.

About Us

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.

For U.S.-based candidates, we offer compelling benefits to our employees, including:

• Health, dental, and vision benefits
• Unlimited Vacation Days for Salaried Full-time Employees
• FSA and Dependent Care Accounts
• Company Paid Disability and Life Insurance
• Generous 401k program
• Paid sabbatical program

4G Clinical is proud to be an Equal Opportunity Employer, and it is foundational to how we recruit and hire our talented team. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by applicable law.