Manufacturing Quality Engineer Lead

5 days ago

Shirley, New York, United States American Regent, Inc. Full time
Nature and Scope

The primary objective of this role is to ensure the timely and accurate completion of investigations and Corrective and Preventive Actions (CAPAs). This position will facilitate communication between Manufacturing, the Process Investigations Team, and Deviations Management, as well as bring visibility to open investigations related to priority for review and disposition of materials. This individual will take a scientific and risk-based approach to demonstrate unwavering commitment to product quality and patient safety.

Essential Duties and Responsibilities
  • Support department subject matter experts in managing Training and qualification requirements, including Aseptic Technique, routine training requirements, skill check evaluations, and employee qualification.
  • 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, Fishbone Diagrams, and others to identify issues affecting product quality.
  • Write technical documents, including SOPs, CAPAs, protocols, batch records, and risk assessments.
  • Utilize 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.
Collaboration and Compliance
  • Collaborate with cross-functional teams to improve aseptic, sanitation, and environmental monitoring (EM) training programs.
  • Ensure compliance with current Good Manufacturing Practices (cGMPs) and other regulatory requirements pertaining to aseptic manufacturing.
  • Participate in audits of aseptic areas and assist in maintaining alignment with facility procedures and expectations.
Additional Responsibilities
  • Partner with the 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 initiatives.
  • Maintain gown qualification for aseptic processing area.
Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • Bachelor's degree in microbiology, Biology, Engineering, or relevant scientific discipline, preferred. Equivalent years of experience to 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, and 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.
Physical Environment and Requirements

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

Employee must be able to occasionally lift and/or move up to 15 pounds.

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