Senior CQV Engineer - Katalyst Healthcares and Life Sciences : Job Details
Senior CQV Engineer
Katalyst Healthcares and Life SciencesJob Location : Bloomington,IN, USA
Posted on :
2025-08-05T08:22:50Z
Job Description :
Responsibilities:
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- Execute commissioning activities, edit/route applicable documents for approvals, and assist with qualification activities for the automated inspection machine (CAT2).
- Maintain document tracker, execution tracker, and list of open items.
- dhere with project schedule for all assigned activities.
- Document impact and risk assessments as part of a team.
- Develop, review, and execute testing documentation.
- Must be willing to work onsite in Bloomington, IN.
- Bachelor's Degree or equivalent required.
- 7+ years' experience in leading CQV activities.
- Must have extensive experience with fully automated syringe inspection machines:
- General understanding of capital equipment implementation and process knowledge.
- Understanding validation documents, URS, IQ, OQ, PQ.
- bility to work independently and as part of a team.
- Strong problem-solving and critical thinking skills.
- GMP and Good Documentation Practice foundational knowledge.
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).
- Basic skills with EXCEL and PowerPoint.
- Strong interpersonal skills and clear communication capabilities.
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