Sr. CSV Specialist

Project Scope and Brief Description: Location: Gap analysis resource will be working at our Haskell-Newark, Delaware site expectation of approximately 50% time on site (or by arrangement) and the rest remote. Must align with time schedules. 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: Haskell Gap Analysis and CSV Specialist: Ability to assess systems via a Gap Analysis with a focus on data integrity practices and gaps, system intended use and validation state. Develop summary and mitigation plans to meet GLP Compliance and best practice. Involves interviewing all system owners, evaluating systems against criteria, documenting validation packages available (working with archivist to pdf all validation packages) to generate plan. Preferred experience in analytical and toxicology related laboratory systems. Lead validation projects identified in gap analysis as prioritized for initial phase 1. Subsequent mitigation is out of scope for this initial project. Responsibilities: General

• 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.

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

• 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
• Project Management experience independent leadership of project
• Experience in evaluating risk and writing test cases to meet acceptance criteria
• Experience validating systems developed under waterfall or agile framework