Senior CQV Engineer
Senior CQV Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- 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.
- Adhere with project schedule for all assigned activities.
- Document impact and risk assessments as part of a team.
- Develop review and execute testing documentation.
Requirements:
- Must be willing to work onsite in Bloomington IN.
- Bachelors 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.
- Ability 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.
Employment Type
Full Time
