Global Quality Validation Representative

Role Profile

Under minimal supervision, the Global Quality Validation Representative based in Kingsport, TN, will take charge of managing cGMP-Regulated Computerized Systems across their lifecycle, ensuring adherence to regulatory standards, Computer Systems Validation (CSV), and Data Integrity requirements. They will oversee validation tasks, steer the generation and authorization of validation documentation, conduct risk assessments, collaborate with project teams to identify elements needing validation, and assess the effects of proposed changes on computerized systems.

Responsibilities

• Develop 21 CFR Part 11 compliant computer systems validation plans, IQ/OQ qualification test protocols, reports, and all documentation, and deliverables within the scope of the validation plan
• Evaluate proposed changes to validated computer systems and recommend level of validation activities required
• Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology
• Generation/execution of validation plans and validation documents
• Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
• Able to work collaboratively and in a client focused environment
• Be highly motivated, organized, and able to manage priorities
• Ability to work with multiple clients and projects
• Have the highest standards for quality, accuracy, and professionalism
• Have excellent communication, presentation, and interpersonal skills
• Perform Periodic Reviews and ensure that the validated state of the computerized systems is maintained
• Must be able to create, review, and update SOPs, forms, templates, documentation, and files.
• Supports regulatory and client audits as CSV subject matter expert.

Qualifications

• A Bachelor’s degree in Computer Science, Engineering or similar discipline with 5+ Years of experience in Computer System Validation activities within pharmaceutical, biotechnology or other manufacturing life science industries regulated by FDA.
• A Master’s degree in Computer Science, Engineering or similar discipline with 3+ Years of experience in Computer System Validation activities within pharmaceutical, biotechnology or other manufacturing life science industries regulated by FDA.
• 3-5 years experience or more performing as Computer System Validation Engineer in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required.

Skills

• Knowledge of 21 CFR Part 11/210/211, Annex 11, Data Integrity, and FDA industry regulations.
• Working knowledge of computerized systems engineering principles.
• Working knowledge and expertise in computerized systems validation.
• Computer System Validation experience with DCS, SAP, LIMS, etc. is preferred.
• Analyzing and troubleshooting problems, identifying solutions and recommending and implementing methods, procedures, systems and/or techniques for resolution.
• Performing necessary projects, assignments to implement goals and objectives for effective, efficient and cost-effective management of allocated resources.
• Functioning as an individual contributor, with minimal supervision.
• Communicating effectively, both orally and in writing.
• Establishing and maintaining cooperative working relationships with those contacted (internal and external) in the course of work.
• Concurrently handle multiple projects and tasks.