Job Description
Virscio is seeking an experienced computer systems validation specialist to perform all aspects of computer systems validation in support of our in vivo preclinical services. The position requires demonstrated expertise in validation of electronic data management and document management systems and prior experience within the pharmaceutical/biomedical research industry.  Familiarity with translational research methods and systems validation within the life sciences industry will be important in assuring effective leadership, planning and communication of system validation projects and delegated specific technical responsibilities.

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 the IT Manager and CTO, ensure the Systems Inventory is up to date at all times

·       Maintain appropriate validation documentation and files according to GLP retention and retrieval requirements for the system

·       Write or assist in the writing of SOPs for CSV related topics and systems

·       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 Senior 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 2 years of related experience in computer systems validation 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 platforms as well as Excel spreadsheets, cloud storage system, DocuSign 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 environments

·       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 regularly internationally from the U.S. to support validation project execution