CSV Engineer

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• 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.
• Assist 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.
• Anticipate 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.

• Mid‑Senior level

• Contract

• Pharmaceutical Manufacturing