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Quality Engineer
Quality EngineerFactoryFix • Carmel, IN
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Quality Engineer

Quality Engineer

FactoryFix • Carmel, IN
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QUALITY ENGINEER - Pharmaceutical Manufacturing

Type : Direct

Hire

Salary : Up

to

$95,000

base

annual

bonus

Benefits : Full

benefits

starting

Day

of

Employment

Work

Schedule : 1st

Shift

Hours

We are partnered with a major pharmaceutical manufacturing company that is seeking a Quality Engineer to join their expanding organization. This role will support the production of high-quality drug products by ensuring compliance with regulatory requirements, investigating deviations, and driving continuous improvement initiatives. The Quality Engineer will work cross-functionally with Operations, Engineering, and Quality teams to maintain and improve manufacturing processes and product quality.

Key Responsibilities

  • Investigate deviations, non-conformances, and out-of-specification results using root cause analysis tools, ensuring corrective and preventive actions are implemented.
  • Support process improvements and reliability initiatives across manufacturing operations.
  • Review and contribute to change controls, batch records, SOPs, and other quality documentation.
  • Participate in internal and external audits to ensure regulatory compliance.
  • Collect, analyze, and report data to identify trends and areas for improvement.
  • Support validation activities, including equipment, process, and cleaning validations.
  • Collaborate with cross-functional teams to resolve quality issues and implement effective solutions.
  • Maintain compliance with cGMP and other applicable regulatory guidelines.

Qualifications

  • Bachelor’s degree in Life Sciences or Engineering required.
  • 2+ years of experience in quality or process engineering in a pharmaceutical manufacturing environment.
  • Experience investigating deviations and applying root cause analysis tools (e.g., 5-Whys, Fishbone / Ishikawa).
  • Familiarity with cGMP and pharmaceutical regulatory requirements.
  • Strong project management, organizational, and communication skills.
  • Proficiency in Microsoft Office applications (Excel, Word, PowerPoint).
  • Lean or Six Sigma certification is a plus.
  • You should be proficient in :

  • 5 Why (Root Cause Analysis Method)
  • Fishbone Diagram (Ishikawa Diagram)
  • FDA Regulations
  • Pharmaceuticals
  • Kaizen
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    Quality Engineer • Carmel, IN

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