Computer System Validation (CSV) Specialist

The CSV Validation Engineer will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems. The incumbent will provide the necessary oversight of system related issues, employ risk-based methodology, and ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle. Additionally, the individual will focus on ensuring consistent policy administration, implementing key improvement initiatives and solving compliance issues.

What will you do?

• Serve as the validation expert for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, manufacturing processes and computer/information/automation validation.
• Perform and/or direct GxP computerized system validation projects in compliance with cGMP, 21 CFR Part 11, Annex 11 and Data Integrity.
• Ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and Thermo Fisher Scientific policies and procedures. Validation projects may include manufacturing systems, lab systems, facilities systems and steady state activities around these applications.
• Plan and establish technical communications, document flow, testing requirements, and resources necessary to complete the validation of a system.
• Support systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention.
• Participate as the validation representative in project team activities and process design to ensure cGMP compliance and interdepartmental consistency within the validation program.
• Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.
• Coordinate and provide training and/or opportunities for career development of others.
• Perform other duties as assigned.

How will you get here?

Education

• Technical Degree or B.S. Degree in Engineering. Degree in Computer Sciences, Computer Engineering is highly preferred.

Experience

• Must have a minimum of four (4) years' experience in a pharmaceutical GMP environment. Must have a minimum of three (3) years direct CSV validation experience.
• Must have working knowledge of at least 5 years of HP ALM
• Candidates with other technical bachelor's degrees will be considered if they have three (3) or more years of direct validation experience.
• Knowledge of IT Control methodologies, including GAMP5 and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity.
• Knowledge in computerized system lifecycle activities, CSV and IT controls in a regulated environment.
• Solid Knowledge of validation of cGMP automation/computerized systems is preferred within an EMA/FDA regulated environment.
• Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
• Experience with system validation across GxP landscape, specifically GMP applications.
• Experience with and knowledge of related quality systems such as Change Control; CAPA (including: Deviations/OOSs); Training; and Document Control is required.
• Experience with the qualification of single use technology is desired.

Knowledge, Skills, Abilities

• Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems and computer system validation in Biotech and/or Pharmaceutical industry
• Excellent communication and listening skills
• Ability to build and maintain strong collaborative relationships across multiple departments
• Microsoft Office and database management skills
• Must know HP ALM with ability to lead projects
• Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.