- Expiry Date: 21 January 2022
Hybrid on-site / remote position. The Computer Systems Validation (CSV) Specialist works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Specialist will partner with Business Owners, Technical Owners and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Specialist will have primary responsibility to ensure that routine tasks supporting validation of electronic systems and applications are documented in accordance with the relevant procedures and regulations. This includes coordination of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and changes to existing systems.
The position has the following requirements:
Bachelor's degree in a life sciences or engineering discipline or equivalent industry experience
2+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records and electronic signatures
Familiar with development of CSV documentation (Validation Plans, Requirements / Specifications / Assessments, Test Scripts [IQ / OQ / PQ], Summary Reports, Trace Matrices, SOPs, etc.)
Familiar with diverse computerized systems, such as computer-controlled laboratory instruments (stand-alone), MES, ERP, LIMS, Validation Lifecycle Management Software, QMS
Experience in following CSV methodology for system evaluations, changes and implementations
Ability to work independently
Experience implementing controls directly supporting Data Integrity efforts is a plus
Primary Duties and Responsibilities:
Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.
Author, review and/or approve applicable CSV documentation
Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures
Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required)
Other related duties as assigned
About ASK:ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.