Senior CQV Engineer

Bloomington, IN (onsite)

Job 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
• 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
• 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