Katalyst CRO

CSA Validation Engineer

6 months ago

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Job Description

Expert in CSA validation principles.
Develop a strategy to convert existing CSV approaches to lab validation into a CSA documented process.
Developing, reviewing, and executing testing documentation.
Direct experience and understanding of complex lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators
Hands on experience with lab techniques and general lab analytical operations.
Understanding of baselined lab standards and system suitability verification.
Basic experience with IT system formats, configurations, and workflows.
General understanding of the business processes supporting one or more domains, such as: Clinical, Quality System Management, Commercialization.
Create and revision of all IT CSV project and system deliverables including but not limited to:

Plans
Requirements
Specifications
Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc.
Summary Reports
Change Controls

Review system operational and administration procedures to ensure they are adequate
Document any findings of non-compliance
Assist with strategy regarding remediation activities
Assist with review of remediation activities
Must be willing to work onsite in Indianapolis, IN
Strong understanding of CSA principles and how to leverage them in a lab validation setting.
Experience in pharmaceutical cGxP setting with the ability to generate CSV deliverables with support of mentor.
Act as the Subject Matter Expert on various pieces of lab equipment
Demonstrated experience in leading lab CSV activities specific to Process Equipment
Ability to work as part of a team.
Experience in GMP regulated environment.
Proven attention to detail and organization in project work.
Capable of working on assigned tasks without mentorship.
Demonstrated ability to generate CSV deliverables independently.