Manufacturing Quality Engineer Lead

American Regent, Inc.•Shirley, NY

2d•$91,000 - $100,000•Onsite

About The Position

The primary responsibilities of the Manufacturing Quality Engineer Lead is to assure timely and accurate completion of investigations and CAPAs. This position will organize and communicate events between Manufacturing, the Process Investigations Team, and Deviations Management as well as bring visibility to open investigations as they relate to priority for review and disposition of materials. This individual will take a scientific and risk-based approach to exemplify unwavering commitment to product quality and patient safety. The Manufacturing Quality Engineer Lead is responsible for partnering with manufacturing Leadership ensuring the training, qualification, and compliance of personnel involved in aseptic manufacturing processes. This is an integrated role that leverages expertise in aseptic training and quality engineering to ensure the safe and compliant manufacturing of pharmaceutical products.

Requirements

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

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 Corrective and Preventive Actions (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.
Collaborate with cross-functional teams to improve aseptic, sanitation, and environmental monitoring (EM) training programs.
Through partnership with manufacturing leadership, 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.
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.
Perform any other tasks/duties as assigned by management.