CSV Specialist
2 weeks ago
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
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