Quality Engineer

2 months ago

Florham Park, United States Celularity Full time
Job DescriptionJob DescriptionDescription:

Celularity Inc., headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies for the treatment of cancer and immune and infectious diseases. Celularity is developing a pipeline of off-the-shelf placental-derived allogeneic cell therapy product candidates including T cells engineered with a chimeric antigen receptor ("CAR"), natural killer ("NK") cells, and mesenchymal-like adherent stromal cells ("MLASCs") and exosomes. These therapeutic candidates target indications across cancer, infectious, and degenerative diseases. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics.

We are seeking a detail-oriented and experienced Quality Engineer to join our biotechnology team. The Quality Engineer will play a crucial role in ensuring compliance with FDA regulations and maintaining high standards of quality throughout our product development and manufacturing processes, specifically focusing on QA review of calibration, equipment qualification, process qualification, and preventative maintenance. The ideal candidate will have a strong background in quality assurance within FDA-regulated environments, particularly in biotechnology or pharmaceutical industries. This role provides Quality oversight of Tissue Products (351/361) and Cell Therapy Products.

Requirements:

Duties and Responsibilities

  • Develop and implement quality assurance processes and procedures in compliance with FDA regulations, including Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), with a specific focus on calibration, equipment qualification, process qualification, and preventative maintenance.
  • Review calibration, qualification and maintenance documents for compliance with regulations, standards and procedures.
  • Conduct risk assessments and develop risk management strategies to mitigate potential quality issues related to calibration, equipment, and process qualifications.
  • Investigate non-conformances, deviations, and customer complaints related to calibration, equipment qualification, and process qualification, and implement corrective and preventive actions (CAPAs).
  • Collaborate with cross-functional teams to resolve quality-related issues specific to calibration, equipment qualification, process qualification, and preventative maintenance, ensuring effective implementation of quality improvements.
  • Review and approve procedures, protocols and reports, focused on calibration, equipment qualification, process validation, and cleaning validation protocols.
  • Provide guidance and training to staff on quality standards, procedures, and regulatory requirements pertaining to calibration, equipment qualification, process qualification, and preventative maintenance.
  • Stay current with industry trends, regulatory requirements, and best practices in Quality Assurance, particularly as they relate to calibration, equipment qualification, process qualification, and preventative maintenance.

Education and Experience

  • Bachelor’s degree in Bioengineering, Biology, or related field. Advanced Degree preferred.
  • Minimum of 3 years of experience as a Quality Engineer (5 years for Senior Quality Engineer) or in a similar role within FDA-regulated industries, preferably biotechnology or pharmaceuticals.
  • In-depth knowledge of FDA regulations, CGMP, GLP, and other relevant quality standards, particularly as they pertain to calibration, equipment qualification, process qualification, and preventative maintenance.
  • Experience with quality management systems (e.g., ISO 13485, 21 CFR Part 820) related to calibration, equipment qualification, process qualification, and preventative maintenance.
  • Strong analytical and problem-solving skills, with a focus on technical aspects of calibration, equipment qualification, process qualification, and preventative maintenance.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment focused on calibration, equipment qualification, process qualification, and preventative maintenance.
  • Detail-oriented with strong organizational skills and the ability to manage multiple priorities, specifically in the context of calibration, equipment qualification, process qualification, and preventative maintenance.
  • Strong knowledge of ICH Q9 Quality Risk Management as it applies to phase-appropriate, particularly related to calibration, equipment qualification, process qualification, and preventative maintenance.

Working Conditions

  • The incumbent will be working in an office environment but will often visit and engage with manufacturing personnel in the laboratories.
  • Flexible scheduling required.
  • Some light lifting may be required occasionally.
  • Must be able to gown aseptically.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities considered incidental or secondary to this job's overall purpose. Employees/contractors holding this position will be required to perform any other job-related duties as requested by management.


Must be authorized to work directly for Celularity in the U.S.


No agency submittals accepted


Celularity is an Equal Opportunity Employer

  • Quality Engineer

    1 week ago

    florham park, United States Capintec, Inc. Full time

    The PCB (Printed circuit board) Quality Engineer is responsible for managing design and production relationships to ensure product integrity and continuously improve manufacturing performance and customer satisfaction throughout the life cycle of Nuclear Medicine products. Responsibilities also include improving the Quality Management System, and general...

  • Quality Engineer

    4 weeks ago

    Florham Park, United States Capintec, Inc. Full time

    The PCB (Printed circuit board) Quality Engineer is responsible for managing design and production relationships to ensure product integrity and continuously improve manufacturing performance and customer satisfaction throughout the life cycle of Nuclear Medicine products. Responsibilities also include improving the Quality Management System, and general...

  • Quality Engineer

    2 months ago

    Florham Park, United States Capintec, Inc. Full time

    The PCB (Printed circuit board) Quality Engineer is responsible for managing design and production relationships to ensure product integrity and continuously improve manufacturing performance and customer satisfaction throughout the life cycle of Nuclear Medicine products. Responsibilities also include improving the Quality Management System, and general...

  • Quality Assurance Engineer

    2 weeks ago

    Florham Park, New Jersey, United States Celularity Full time

    Quality Engineer at Celularity Inc.Celularity Inc. is a pioneering biotechnology firm dedicated to advancing placental-derived cell therapies aimed at treating a variety of health conditions. We are seeking a meticulous Quality Engineer to uphold compliance with regulatory standards and ensure exceptional quality throughout product development. The role...

  • Quality Assurance Engineer

    1 week ago

    Florham Park, New Jersey, United States Capintec, Inc. Full time

    Position Overview:The Quality Assurance Engineer plays a crucial role in maintaining product excellence and enhancing manufacturing efficiency for Nuclear Medicine solutions. Core Responsibilities:- Ensure product compliance with relevant industry regulations.- Foster collaboration between design and production teams.- Lead initiatives for continuous quality...

  • Quality Assurance Engineer

    1 week ago

    Florham Park, New Jersey, United States Celularity Full time

    Quality Engineer at Celularity Inc.Celularity Inc. is a pioneering biotechnology firm dedicated to the advancement of placental-derived cell therapies aimed at treating a variety of health conditions. We are seeking a meticulous Quality Engineer to uphold compliance with regulatory standards and ensure exceptional quality in our product development...

  • Electronics Quality Engineer

    2 weeks ago

    Florham Park, New Jersey, United States Mirion Technologies (Capintec), Inc. Full time

    Job OverviewThe PCB Quality Assurance Engineer plays a crucial role in overseeing the integrity of product design and production processes, ensuring high standards of quality throughout the lifecycle of Nuclear Medicine products. This position is essential for enhancing the Quality Management System and providing comprehensive quality support in both...

  • Quality Assurance Engineer

    2 weeks ago

    Florham Park, New Jersey, United States Celularity Full time

    Quality Engineer at Celularity Inc.Celularity Inc. is a pioneering biotechnology firm dedicated to advancing placental-derived cell therapies aimed at treating a variety of medical conditions. We are seeking a meticulous Quality Engineer to uphold compliance with regulatory standards and ensure exceptional quality throughout the product development...

  • PCB Quality Engineer

    2 months ago

    Florham Park, United States Mirion Technologies (Capintec), Inc. Full time

    Job DescriptionJob DescriptionThe PCB (Printed circuit board) Quality Engineer is responsible for managing design and production relationships to ensure product integrity and continuously improve manufacturing performance and customer satisfaction throughout the life cycle of Nuclear Medicine products. Responsibilities also include improving the Quality...

  • PCB Quality Assurance Engineer

    2 weeks ago

    Florham Park, New Jersey, United States Entegee Full time

    Job OverviewPosition Summary: We are in search of a PCB Quality Assurance Engineer who will play a crucial role in maintaining product quality, enhancing manufacturing efficiency, and advancing the Quality Management System for Nuclear Medicine products.Key Responsibilities: Ensure finished products meet drawing specifications in accordance with customer and...

  • PCB Quality Assurance Engineer

    2 weeks ago

    Florham Park, New Jersey, United States Mirion Technologies (Capintec), Inc. Full time

    Job OverviewThe PCB Quality Assurance Engineer plays a crucial role in overseeing the relationships between design and production teams to guarantee product quality and enhance manufacturing efficiency and customer satisfaction throughout the lifecycle of Nuclear Medicine products.Core Responsibilities:Ensure that finished products comply with specifications...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Florham Park, New Jersey, United States Infotech Sol Full time

    Position Overview:Lead Quality Assurance EngineerWe are in search of a Lead Quality Assurance Engineer with a robust background of over 7 years in the field to enhance our operations at Infotech Sol. If you possess a strong commitment to maintaining exceptional quality standards across all facets of our services, this role could be an excellent fit for you....

  • Quality Control Engineer for PCB Manufacturing

    2 weeks ago

    Florham Park, New Jersey, United States Mirion Technologies (Capintec), Inc. Full time

    Job OverviewThe PCB Quality Assurance Engineer plays a crucial role in overseeing the integrity of products throughout the lifecycle of Nuclear Medicine solutions. This position is dedicated to fostering robust design and production collaborations to enhance manufacturing efficiency and elevate customer satisfaction.Core Responsibilities:Ensure that...

  • Lead Quality Assurance Engineer

    4 weeks ago

    Florham Park, United States Matlen Silver Full time

    Job Title: QA Engineer (Salesforce Admin Exp)Duration: 3-6 months (CTH) on W2Location: Hybrid Onsite in Florham Park, NJRequired Pay Scale: $60 - 65/hr W2***Due to client requirements this role is only open to USC or GC candidates***Job Summary: This Lead QA Engineer will be in charge of Data Support when data is being sent to the Salesforce CRM tools, if...

  • Lead Quality Assurance Engineer

    4 weeks ago

    Florham Park, United States Matlen Silver Full time

    Job Title: QA Engineer (Salesforce Admin Exp)Duration: 3-6 months (CTH) on W2Location: Hybrid Onsite in Florham Park, NJRequired Pay Scale: $60 - 65/hr W2***Due to client requirements this role is only open to USC or GC candidates***Job Summary: This Lead QA Engineer will be in charge of Data Support when data is being sent to the Salesforce CRM tools, if...

  • Lead Quality Assurance Engineer

    4 weeks ago

    Florham Park, United States Matlen Silver Full time

    Job Title: QA Engineer (Salesforce Admin Exp)Duration: 3-6 months (CTH) on W2Location: Hybrid Onsite in Florham Park, NJRequired Pay Scale: $60 - 65/hr W2***Due to client requirements this role is only open to USC or GC candidates***Job Summary: This Lead QA Engineer will be in charge of Data Support when data is being sent to the Salesforce CRM tools, if...

  • PCB Quality Assurance Specialist

    1 week ago

    Florham Park, New Jersey, United States Capintec, Inc. Full time

    Position Overview:The Quality Assurance Engineer at Capintec, Inc. plays a crucial role in maintaining product excellence and enhancing manufacturing efficiency, particularly for Nuclear Medicine solutions. Key Responsibilities:- Ensure product compliance with relevant industry regulations.- Foster collaboration between design and production teams.- Lead...

  • PCB Quality Assurance Specialist

    2 days ago

    Florham Park, New Jersey, United States Entegee Full time

    Job OverviewEntegee is seeking a highly skilled PCB Quality Assurance Specialist to join our team. As a key member of our Operations department, you will be responsible for ensuring the highest quality standards in our custom automation projects.Key ResponsibilitiesVerify compliance of finished assemblies with drawing requirements based on customer and...

  • Senior Quality Assurance Lead

    2 weeks ago

    Florham Park, New Jersey, United States Matlen Silver Full time

    Position: Lead Quality Assurance EngineerContract Duration: 3-6 months (Contract to Hire)Work Arrangement: Hybrid OnsiteCompensation Range: $60 - $65 per hour***This position is exclusively available for U.S. Citizens or Green Card holders due to client specifications.***Role Overview: The Lead Quality Assurance Engineer will oversee data integrity during...

  • PCB Quality Technician

    2 months ago

    Florham Park, United States Mirion Technologies Full time

    The PCB (Printed circuit board) Quality Technician is responsible for performing visual, mechanical, electrical, and quality monitoring inspections of material, processes, and electro-mechanical product. The position will oversee the Verification, Calibration, and minor Preventative Maintenance of equipment and tools used within Florham Park, plus perform...