Job Description

Quality Engineer – Pharmaceutical Manufacturing**

Location: Carmel, IN

Type: Direct Hire

Salary: Up to $95,000 base + bonus

Benefits: Full benefits starting Day 1 **

Summary of Position

We are seeking a Quality Engineer to join a growing pharmaceutical manufacturing 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.

Work Schedule: 1st Shift Hours

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