Sr. Computer System Validation (CSV) Specialist

Project Scope and Brief Description:

Responsible for ensuring all assigned laboratory equipment/software, IT systems and associated infrastructure, within the R&D GLP environment and cloud environments, is in a qualified, validated state. Responsible for leading management, creation and review of validation deliverables and testing while following all applicable regulations and data integrity best practices

Special Focus:

Deep expertise in validating systems such as LabVantage, or other end to end LIMS/ELN/LES like systems for fully electronic laboratory workflows; Chromeleon or other chromatography systems; Analytical Instrumentation especially used to generate a certificate of analysis integrated with LIMS/LES/ELN system; Lab Automation; Electronic signatures; and Electronic Archiving of edata. Experience developing requirements and qualification for infrastructure to support validated systems.

Responsibilities:

• Partner with lab scientists and technicians, engineers, IT, QAU and vendors in managing and/overseeing the completion of qualification and validation activities associated with installation, maintenance, and upgrades of equipment or systems to ensure they are completed in a compliant and timely manner.
• Create, execute and/or review GLP/GMP Laboratory equipment/software, IT systems and associated infrastructure qualification and validation related documentation.
• Assess, author and or approve change control, incidents, deviations and investigations related to computer systems using a risk-based approach.
• Contribute to computer validation related SOPs.
• Contribute to the strategic effort to move to electronic workflows with eData and esignatures.
• Monitor equipment inventory and system validation status.

• Train lab scientists, technicians, IT personnel and Quality Assurance Unit (QAU) personnel, as needed, on qualification/validation requirements and procedures.
• Participate in life cycle management of equipment and software thru periodic reviews, change/incident management and retirement after initial validation.
• Conduct work according to Good Laboratory Practices (GLP).
• Maintain up-to-date knowledge of GLP and Computer Systems Validation (CSV) requirements through training and participation in external forums.
• Represent the company internally in the area of CSV.
• Analyze test data to ascertain if it meets related protocol acceptance criteria. Write deviation reports as required upon failure to meet protocol acceptance criteria.
• Assist with the development and communication of project timeline and status.
• Assist with vendor audits.

Education

• Bachelor's Degree preference if scientific, IT or Engineering.
• 5+ yrs in Validation preferred direct responsibility for projects and leading entire validation process.

Skills

• Project Management experience independent leadership of project
• Strong verbal and written communication and documentation skills
• Experience coordinating and conducting qualifications and validations on IT systems and scientific equipment with associated software in a timely manner
• Demonstrated experience in developing requirements with system owners based on workflow analysis and discussion integrating in Risk & data integrity mitigations.
• Experience working in regulated R&D environment: analytical instrumentation and LIMS, ELN, Chromatography and Inventory systems preferred.
• Knowledge of Good Lab Practices (GLP) or other GxP practices with a focus on Data Integrity improvements and risks
• Knowledge of industry validation standards, guidelines and regulations such as GAMP 5, OECD, EPA and FDA, 21 CFR Part 11
• Knowledge of system and requirement level risk management process and analysis
• Ability to support a large technical customer base with effective facilitation skills
• Excellent understanding of software development life cycle process
• Experience in evaluating risk and writing test cases to meet acceptance criteria
• Experience validating systems developed under waterfall or agile framework