CSV Engineer

Indianapolis, IN, US • Posted 60+ days ago • Updated 11 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Test Plans
Editing
Testing
Dashboard
Change Management
Mentorship
Quality Assurance
Onboarding
Training
Management
Regulatory Compliance
Computerized System Validation
Pharmaceutical Industry
Pharmaceutics
Test Management
Microsoft Office
Collaboration
Communication
Documentation
Document Management

Summary

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.

Requirements:

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 98222ab01e9121c4c7553bdfe76833a5
Posted 30+ days ago

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