Manufacturing Quality Engineer Lead

About the Role The Manufacturing Quality Engineer Lead will assure timely and accurate completion of investigations and CAPAs, coordinating across Manufacturing, the Process Investigations Team, and Deviations Management. The role combines aseptic training with quality engineering to ensure safe and compliant manufacturing of pharmaceutical products and requires a scientific, risk-based approach to product quality and patient safety. What You'll Do

• Initiate, oversee, or assist in investigations and CAPAs related to aseptic process deviations and quality incidents.
• Perform root cause analysis using tools such as 5 Whys and Fishbone Diagrams to identify issues affecting product quality.
• Write technical documents including SOPs, CAPAs, protocols, batch records, and risk assessments.
• Use project management tools to drive CAPAs to timely completion.
• Serve as a liaison between Manufacturing, Quality, and other departments to ensure timely resolution of quality issues and regulatory compliance.
• Support Manufacturing personnel in data collection activities and documentation preparation.
• Collaborate with cross-functional teams to improve aseptic, sanitation, and environmental monitoring training programs.
• Ensure compliance with current Good Manufacturing Practices (cGMPs) and regulatory requirements pertaining to aseptic manufacturing.
• Participate in audits of aseptic areas and maintain alignment with facility procedures.
• Partner with Training Department to support Aseptic Media Fills by facilitating training, scheduling personnel, and ensuring interventions are performed correctly.
• Participate in risk reviews and provide expertise on aseptic technique as related to interventions and processes.
• Prepare and present data and metrics during operational meetings to drive continuous improvement.
• Maintain gown qualification for aseptic processing area.
• Perform any other tasks/duties as assigned by management. What We're Looking For
• Bachelor's degree in Microbiology, Biology, Engineering, or relevant scientific discipline; equivalent years of relevant experience may be considered.
• Minimum 2-5 years of experience in pharmaceutical microbiology, sterile manufacturing, environmental monitoring, and/or quality engineering.
• Expertise in aseptic techniques, gowning procedures, environmental monitoring requirements.
• Experience with regulatory requirements (cGMP, FDA, etc.) and quality systems (CAPA, deviation management).
• Excellent communication skills, both verbal and written, with the ability to interact effectively at all organizational levels.
• Proficiency in MS Office Suite and project management tools.
• Flexibility to work across shifts and adapt to changing priorities in a dynamic manufacturing environment. Compensation & Benefits
• Salary range: USD 91,000 - 100,000 per year.
• American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.