Computer System Validation Tech

Job Title : Computer System Validation Tech

Job Location : Raleigh NC 27616

Onsite Requirements :

• Writing test Cases - UA testing
• Validation experience
• ERP (Oracle preferred) or SaaS experience

Job Description :

• Ensure that global computerized systems are implemented appropriately through validation and / or user acceptance testing, the system performs / operates as specified, and that the system is maintained through requalification and periodic review efforts.
• This individual is responsible for writing, executing, and summarizing qualification and validation protocols, assisting in the development and maintenance of specification documents (URS / FRS / CS / DS), traceability matrices, and taking part in the development of validation plans.
• This position will also assist user groups in troubleshooting and analyzing computerized systems and lead the resolution of deviations noted during a system's lifecycle.
• Coordinate and lead Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities to ensure company computerized systems are in full compliance with regulatory requirements, company policies, and procedures,
• Serve as the subject matter expert to provide compliance and oversight to cross-functional team's CSV and / or CSA projects,
• Collaborate with business partners to shepherd CSV and CSA processes to ensure robust, efficient, and compliant processes,
• Serve as the CSV / CSA referent to management and business partners involved in CSV / CSA projects.
• Carries out activities related to GxP and non-GxP testing of software-based systems intended for Global usage by the client.
• Write, execute, summarize and review GxP and non-GxP protocols. Evaluate and analyze data for accuracy and sufficiency.
• Leads the development of new and revised lifecycle specifications and assessments.
• Identify and support the resolution of deviations noted during protocol execution;Take part in the resolution of departmental related deviations.
• Collaborates with project teams to support computerized system implementation, upgrades, and provide technical input and expertise as needed.

Demonstrates and supports the client values.

• Follow departmental and Global / company-wide SOPs and policies, including Global Computerized System VMP and Policies.
• Supports global compliance with alignment of global validation program, FDA and EudraLex regulations.
• Responsible for authoring, revising, and maintaining Validation Master Plans of Global Computerized Systems.
• Adheres to requalification and periodic review schedule for computerized systems and IT processes per procedure and established plans;

Analyzes and summarizes periodic reviews of previously validated computerized systems and develop / implement protocols / changes based on outcome of the review.

Experience :

• Bachelor's degree, in a technical / science / mathematical field, preferred. 4+ years validation experience in a biotech / pharmaceutical environment.
• Specializing in 1 or more areas such as laboratory instrument qualification, Agile Software Development Methodology, Computer Software Assurance, or Computerized System Validation.
• Experience with using Off-the-shelf, Configured-Off-The-Shelf (COTs), and Bespoke Computerized Systems such as CRM, LMS, ERP, LIMS, ELN, etc.
• Experience with SAAS, IAAS, and PAAS software implementations.
• Strong written and oral communication skills with ability to interact with various individuals and roles throughout the organization and with external consultants.
• Technical writing background;able to read / analyze / interpret common scientific / technical documents.
• Exposure to industry guidelines including CSV, CSA, SOx, cGMPs, regulatory guidelines (i.E. : FDA, EU, ICH, ISO), internal auditing, handling of regulatory inspections.

3rd party and subcontract staffing agencies are not eligible for partnership on this position. 3rd party subcontractors need not apply.

This position requires candidates to be eligible to work in the United States, directly for an employer, without sponsorship now or anytime in the future.