Nature and Scope
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.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Training and Qualification
Support department subject matter experts in managing Training and qualification requirements including Aseptic Technique, routine training requirements, skill check evaluations and employee qualification.
Quality Engineering
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.
Collaboration and Compliance
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.
Additional Responsibilities
Partner with the Training Department, 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.
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. 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, 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.
Expected Salary Range:
$91,000 - $100,000
The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
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.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and 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.
Applicants have rights under Federal Employment Laws.
FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
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