Manufacturing Quality Engineer Lead

Nature and Scope

The Manufacturing Quality Engineer Lead ensures timely and accurate completion of investigations and CAPAs, organizes and communicates events between Manufacturing, Process Investigations, and Deviations Management, and brings visibility to open investigations related to priority review and disposition of materials. This role takes a scientific, risk‑based approach to product quality and patient safety and partners with manufacturing leadership to ensure training, qualification, and compliance of personnel involved in aseptic manufacturing processes.

• Support training and qualification of personnel in aseptic technique, routine training requirements, skill check evaluations, and employee qualification.
• Initiate, oversee, or assist 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 quality issues.
• Write technical documents including SOPs, CAPAs, protocols, batch records, and risk assessments.
• Use project management tools to drive critical CAPAs to timely completion.
• Act as a liaison between Manufacturing, Quality, and other departments to ensure timely resolution of quality issues and compliance with regulatory requirements.
• 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 (cGMP) and other regulatory requirements.
• Participate in audits of aseptic areas and assist in maintaining alignment with facility procedures.

• Partner with the Training Department to support Aseptic Media Fills by facilitating training, scheduling personnel, and ensuring correct execution of interventions.
• Participate in risk reviews and provide expertise on aseptic technique related to interventions and processes.
• Prepare and present data and metrics during operational meetings to drive continuous improvement initiatives.
• Maintain gown qualification for aseptic processing area.
• Perform any other tasks or duties as assigned by management.

Bachelor’s degree in microbiology, biology, engineering, or a related scientific discipline (preferred). Minimum 2–5 years of experience in pharmaceutical microbiology, sterile manufacturing, environmental monitoring, and/or quality engineering. Expertise in aseptic techniques, gowning procedures, and environmental monitoring requirements. Experience with regulatory requirements (cGMP, FDA, etc.) and quality systems (CAPA, deviation management). Excellent verbal and written communication skills and 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.

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. Must be able to occasionally lift and/or move up to 15 pounds.

$91,000 – $100,000 per year.

American Regent is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.