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Quality Engineer

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Date: Jun 6, 2025

Location: Congers, NY, US, 10920

Company: Aptar Group

Quality Engineer

Work Location: Congers NY

 

Improving Health through Science and Technology!  At Aptar Pharma, we specialize in Drug Delivery offering Innovative Devices, Services and Solutions focused on Patient Experience.  Aptar Pharma is part of Aptar Group, a global leader of dispensing systems for the packaging industry.  Aptar Pharma has been setting the standard in drug delivery for decades providing health technology solutions and services enabling effective patient treatment.  Be You, Be Aptar! 

 

What You Will Do at Aptar Pharma:

 

The Quality Engineer (QE) is primarily responsible for the design and execution of qualification & validation activities, leading the implementation of new or modification of existing manufacturing equipment/processes (e.g. Injection Molding, Assembly), analytical testing equipment and/or facility related systems (e.g. Cleanroom, process gases), in accordance with defined requirements, and customer expectations at the Congers, NY facility. The QE will bring a high-level quality mindset to validations and design transfer, ensuring these activities are thoroughly executed and properly documented in compliance with ISO 15378. The employee will also be involved in leading or supporting continuous improvement initiatives.

 

What Aptar Pharma Is Looking For:

Primary Duties and Responsibilities:

 

  • Responsible for leading and executing validation activities in a fast-paced cGMP manufacturing environment: review and approve executed qualification /validation documents, for facilities, processes, and equipment.
  • Preparing of validation protocols/reports (e.g. IQ, OQ, PQ), ensuring compliance and adherence to the design, customer and internal quality requirements, as applicable.
  • Identify process and product quality non-conformances identified through the execution of validation activities
  • Conduct, and/or participate in deviation investigations to identify root causes and define corrective/ preventative actions (CAPAs).
  • Organize engineering runs and validation activities with cross-functional teams (e.g. Production, Quality Control, Technical Operations) to meet project objectives.
  • Lead training of cross-functional teams involved in validation related activities.
  • Supports quality system, and manufacturing process improvement initiatives and analyze product performance to identify trends as necessary.
  • Liaise with European design centers to ensure that design transfer and validation practices align with global requirements.
  • Drive technical quality and validation activities to completion in accordance with project objectives/timelines, including organizing routine follow-ups during after execution to ensure compliance
  • Supporting document creation, revisions, or reviews as needed
  • Prepare customer communication for validation summaries, including deviation and CAPA summaries as needed.
  •  Support process and product improvement initiatives and analyze product performance to identify trends.
  •  Support customer complaint investigations, as needed

 

What you will bring on the journey:


Education:

  • Bachelor’s Degree or equivalent work experience in Engineering or other technical discipline

  Experience:

  • 1 to5 years’ of professional experience working in a regulated manufacturing environment (pharmaceutical / medical devices a plus);
  • Experience data collection, data analysis, technical writing.
  • Knowledge and experience with Root Cause Analysis (RCA), CAPA, Quality Risk Management, FMEAs and other key quality tools is a plus
  • Knowledge of cGMPs, ISO 15378, 21CFR Part 11, Part 211 and/or 820 regulations is a plus

 

Skills/Abilities:

  • Strong problem solving and critical thinking skills
  • Self-Starter with excellent written and communication skills.
  • Able to work with a diverse cross-functional team with minimal supervision.
  • Quality Engineering concepts such as statistical analysis, quality testing, sampling and inspection, process control is a plus
  • Experience with Statistical Software (e.g. Minitab) is a plus
  • Travel; sometimes

 

 

What We Offer

  • An exciting, diverse and value based working environment.
  • Award-winning corporate university offering personal development and training opportunities.
  • Competitive base salary
  • Contribute to the communities where we reside.
  • Innovative benefits plan which includes 401k plan with Company matching benefit, paid time off, medical, dental, vision, life, disability and more

Compensation and Base Annual Pay
In compliance with pay transparency requirements, the salary range for this role is USD $78,000.00 to USD $105,000.00 annually. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. Aptar also offers a variety of benefits, including health, life, and disability insurance, 401(k) match and employer retirement savings contribution, flexible spending accounts, EAP, education assistance, parental leave, paid time off, company-paid holidays, and more. The specific programs and options available to an employee may vary depending on location, pay class, or other factors.

 

BE YOU, BE APTAR!

Aptar is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information

Aptar Pharma, NA
250 Route 303 North
Congers, NY 10920
www.aptar.com

 

Improving Health through Science and Technology!

Nearest Major Market: New York City

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Nearest Major Market: New York City