What are the responsibilities and job description for the CSV Engineer position at Katalyst Healthcares and Lifesciences?
Job Details
Responsibilities:
- Interface with client Subject Matter Experts, Site and Area Management, Quality Assurance, and other stakeholders for validation planning.
- Guide the creation and updates of project validation planning deliverables such as Validation, Security, and Test Plans.
- Support execution of validation activities in alignment with the approved Validation Plan and CSV documentation standards.
- ssist Project CSV Leads in generating/editing CSV documents and electronic testing templates.
- Recommend improvements to ensure compliance and consistency across all CSV deliverables.
- Support creation of reports, dashboards, and queries within change management, document management, and electronic test systems.
- Provide mentoring and guidance to SMEs and project team members.
- Promote a culture of reliability and compliance within CSV processes.
- Collaborate closely with Quality Assurance personnel to ensure alignment with quality and compliance expectations.
- Support onboarding, training, and workload management for validation personnel.
- nticipate future validation needs and trends to maintain system compliance.
- Bachelor's degree in engineering or equivalent.
- Minimum 10 years of experience in CSV within the pharmaceutical industry.
- Proven experience in large-scale pharmaceutical automation or program environments.
- Hands-on experience with Kneat electronic test management systems.
- Proficiency in Microsoft Office and web-based documentation tools.
- Strong collaboration, communication, and documentation skills.
- Prior exposure to electronic document management systems preferred.
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