CQV Engineer / Senior Validation Engineer
A fast-growing consulting firm in the life sciences sector is seeking a motivated CQV Engineer to support commissioning, qualification, and validation (CQV) activities for process equipment. This is an ideal opportunity for professionals looking to contribute to regulated manufacturing environments while building deep technical and regulatory expertise.
Key Responsibilities:
Prepare and execute CQV protocols including URS, IQ, OQ, and PQ documentation
Run test scripts and document outcomes related to process and automated systems
Conduct user interface checks, software verifications, and alarm testing
Maintain organized and compliant qualification records
Collaborate with cross-functional teams to meet project timelines
Assist with impact and risk assessments as part of a validation team
Suggest process or design improvements based on test results
Support implementation of capital equipment and process improvements
Leverage QMS tools (e.g., TrackWise) to track issues and manage quality records
What We're Looking For:
Bachelor's degree or equivalent in a relevant scientific or engineering discipline
Experience in CQV activities within a GMP-regulated setting
Familiarity with quality management systems and documentation standards
Strong understanding of GMP and Good Documentation Practices
Proficient with Microsoft Office, especially Word (working with large technical docs)
Strong communication and interpersonal skills
Comfortable operating independently and as part of a team
Able to manage competing priorities and work in dynamic environments
Additional Details:
This is a fully on-site role based in Bloomington, IN
Salary is based on experience, skill set, and business need. Actual compensation may vary.
Benefits Include:
Competitive salary plus performance bonuses
Comprehensive health, dental, and vision insurance
Company-paid life and disability insurance
Flexible Spending Accounts (FSA) and Health Savings Account (HSA) options
401(k) retirement plan with employer matching
Generous paid time off, holidays, and as-needed sick leave
Tuition reimbursement and professional development support
Paid parental leave and bereavement
Employee referral bonuses, team events, and recognition programs
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