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Position: CSV Specialist

Duration: 6+ months contract

Location: Newark, DE

Job Description:

Our client is a large global agricultural company focused on innovative solutions in crop protection, seeds, digital agriculture, and service.

Responsible for ensuring all laboratory equipment/software, IT systems and associated infrastructure, within the R&D GLP environment, GMP manufacturing (as applicable) and cloud environments, is in a qualified, validated state by supporting management, creation and review of validation activities.

The CSV Specialist reports to the CSV Team Lead or Sr. Validation Specialist.

Interacts with

• Close: Lab Scientists & Technicians in the Regulated laboratories, Lab Operations and Technical Services (LOTS) team, Quality Assurance Unit, CSV Team Members, Engineers and Operators within Facilities and Manufacturing as applicable.
• Others: Enterprise IT, Research IT specialists/Devops and administrators, Regulated Lab leaders and managers (Test Facility Management -TFM, GMP leaders), Quality Managers.

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 Laboratory equipment/software, IT systems and associated infrastructure qualification and validation related documentation
• Assess, author and or approve IT change control, incidents, deviations and investigations related to computer systems using a risk-based approach.
• Develop, revise and maintain computer validation related SOPs.
• Contribute to the long-term strategic effort to incorporate eData and esigs
• 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 management and retirement after initial validation.
• Conduct work according to Good Laboratory Practices (GLP)
• Maintain up-to-date knowledge of GLP/GMP and Computer Systems Validation (CSV) requirements through training and participation in external forums
• Represent the company internally and externally in the area of CSV
• Analyze 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.

Required Skillset

• Experience coordinating and conducting qualifications and validations on IT systems and scientific equipment with associated software in a timely manner
• Experience working in regulated R&D environment
• Knowledge of Good Lab Practices (GLP) or other GxP practices with a focus on Data Integrity
• Knowledge of industry validation standards, guidelines and regulations such as GAMP 5, OECD, EPA and FDA, 21 CFR Part 11
• Knowledge of software 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
• Strong verbal and written communication skills
• Project management Experience