About Careertakes

👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Engineering.

Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.

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What You’ll Do

This confidential client is seeking a CQV Engineer to support change control and deviation management activities in a regulated cGMP manufacturing environment. The role focuses on assessing, documenting, and executing manufacturing and system changes while maintaining compliance and validated states.

• Author, review, and manage change controls affecting systems, equipment, and processes
• Perform impact assessments that evaluate product quality, validated state, and regulatory implications
• Support execution of change control deliverables and update related documentation and tracking systems
• Participate in deviation investigations and support root-cause analysis and corrective actions
• Review and approve technical documentation and validation deliverables as required
• Provide subject-matter-expert (SME) support for audits and inspections tied to change control and deviation processes
• Collaborate with Analytics, Quality Assurance, Engineering, and Scientific teams to align on change implementations and timelines
• Support continuous improvement initiatives for CQV and quality system processes

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Who You Are (Qualifications)

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related field
• 1–3 years’ experience in CQV, Validation, or Quality Engineering within a regulated industry (entry-level candidates encouraged)
• Hands-on experience with change control systems and documented change management workflows
• Working knowledge of cGMP and Good Documentation Practices (GDP)
• Familiarity with analytical testing methods and basic chemistry concepts preferred
• Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus
• Strong technical writing and documentation skills
• Excellent communication and cross-functional collaboration abilities

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Location & Employment Type

• Onsite — Indianapolis, IN
• Full-time

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Compensation & Benefits

• National (US) Salary Range: $69,300 - $102,623 per year (actual pay dependent on experience and other job-related factors)
• Benefits offered by the confidential client include:
  • Medical, Dental & Vision insurance
  • Company-paid Life, Short-Term, and Long-Term Disability
  • Health Savings Account (HSA) and Flexible Spending Accounts (FSA)
  • 401(k) with employer match
  • Paid Time Off (PTO), holidays, and as-needed sick time
  • Tuition reimbursement and professional development
  • Employee recognition and referral programs
  • Paid parental leave and bereavement benefits
  • Commuter benefits and team social activities

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Additional Information

• This role requires onsite presence in Indianapolis, IN.
• The confidential client is committed to maintaining compliance with applicable data privacy rules for applicant data.

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Equal Opportunity & Hiring Transparency

Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.

If you have questions about how your data is used, please contact us directly.