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 RegulationsPharmaceuticalsKaizen