Computer Systems Validation Specialist

Job Description

Virscio is seeking an experienced Computer Systems Validation Specialist to perform all aspects of computer systems validation in support of our preclinical services. This hybrid or on-site position requires demonstrated expertise in validation of electronic data, document, and Laboratory Information Management Systems, and prior experience within the pharmaceutical/biomedical research industry.  Familiarity with translational research methods and 21 CFR Part 11 and GLP requirements for systems validation within the life sciences sector will be important in assuring effective leadership, planning, communication, and execution of system validation projects and delegated specific technical responsibilities. Depending upon the experience of candidate, we will consider various levels when filling this role.

Responsibilities

·       Manage the full lifecycle of system validation projects, ensuring the delivery of a quality validation project at all times

·       Write and assist in writing all validation deliverables within the computer system lifecycle, e.g. validation plans, summary reports, configuration specifications, and change control

·       When assigned a system administrator role for a computer system, manage ongoing administration activities such as user access security, periodic system review, computer system incident resolution and change control

·       In conjunction with IT Department and Chief Technology Officer, ensure the Systems Inventory is up to date at all times

·       Manage cross functional teams involved in the validation project deliverables (e.g., Project Team, IT team, Quality Assurance team, vendors, etc.)

·       Coordinate validation project meetings and migrate plans to Wrike project management platform with appropriate assignment of tasks to team in a timely and clear manner

·       Train staff on their roles across different validation projects as required

·       Report any non-compliances of Quality Management System with respect to validation to the Testing Facility Management

·       Develop and implement solutions to validation issues.

·       Present validation systems program during internal and external audits

·       Establish an in-depth knowledge of facility SOPs and contribute to their maintenance.

·       Contribution to maintenance of good laboratory practices (GLPs) and AAALAC credentials.

·       Perform all other assigned duties.

Education/Experience Requirements

·       Requires Bachelor’s degree (B.A. or B.S.) or equivalent in computer sciences, scientific or related discipline.

·       Minimum of 8 years of experience in computer systems validation role.

·       Minimum of 2 years of related experience performing computer systems validation activities within a GxP-compliant environment.

·       Comprehensive knowledge of regulatory requirements, including GLPs and Part 11, with respect to computerized systems, is preferred.

·       Candidates with prior experience in the validation of Xybion Pristima or equivalent EDMS or LIMS platforms as well as Excel spreadsheets, cloud storage systems and platforms commonly used in the research setting are strongly encouraged to apply.

Additional Requirements

·       Responsive, proactive mentality.

·       Demonstrated ability to adapt to the necessities of fast-paced multi-site research environment.

·       Exceptional attention to detail with a focus on quality of service and team communication.

·       Must have exceptional interpersonal, communication and presentation skills and comfort interacting with management, sponsors and internal/external auditors.

·       Ability to travel internationally from the U.S. to support validation project execution (less than 10% travel).

Virscio offers a competitive, flexible, and comprehensive benefits package that can be customized to fit your personal needs. Virscio’s benefits offering is designed to support the holistic wellbeing of our employee community and their families by providing affordable healthcare related coverages, retirement savings plan with immediate vesting, and a wide range of voluntary benefits for financial protection and peace of mind. Additionally, we offer a Culture of CARE where your health, well-being and gratification in career pursuits is our top priority. 

Our commitment to you is a culture of care and support in which you feel engaged, empowered, and passionate about the work that you perform while working collaboratively and with empathy towards others. 

Virscio is bridging the translational gap with critical research on solutions to significant unmet health challenges. Every day, our community brings their best selves to their work to advance this initiative. Join us on our journey and become part of our caring community.