At Saint-Gobain we design, manufacture and distribute materials which are key ingredients in the wellbeing of each of us and the future of all. Join our innovative, passionate and entrepreneurial community to improve the world of tomorrow with us.
The Quality Engineer I/II will support the Quality Manager to ensure that the Quality Management System and quality standards of the Company are implemented and maintained at the Gaithersburg facility in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations. The Gaithersburg, MD site is a custom manufacturer for the biopharmaceutical and cell therapy industries and is an ISO 13485 site and registered with the FDA. This position is responsible for 2 strategic focused factories, both of which support critical application end use products for gene therapy, cell therapy and final fill biopharmaceutical applications.
Lead and/or support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including:
Document control and review/approval of controlled documents
Change management and review of change controls
Investigation and CAPA management, including robust root cause analysis
Complaint management and performance of complaint investigations
Supplier quality management and performance of supplier audits as appropriate
Internal audit program and performance of internal audits
Training program; conduct training when needed
Implementation of Quality Risk Management in relevant aspects of the QMS
ISO certification and maintenance
Lead and/or support the oversight of product realization and commercial manufacturing activities, such as product/specification development, environmental monitoring, out of specifications, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management.
Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product.Manage sterilization validation program
Customer support, including:
Support customer audits, including response and corrective action tracking
Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication.
Bachelor's Degree - Life Sciences or Engineering
3-5 years experience in a regulated industry, such as life sciences, food and beverage, or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device).
1-3 years experience in a Quality role (Quality System development, implementation, and/or execution) within a manufacturing environment.
Strong knowledge of ISO and/or cGMP requirements and relevant industry standard practices is required. Demonstrated ability to interpret these regulations to ensure proper implementation in the plant systems.
Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment.
Proficient computer skills required including Microsoft Word, Excel, Visio, PPT, and Project
Gaithersburg is a Horizon 3 site that introduces entirely new elements to the Saint-Gobain Life Sciences business that do not exist today at the same time as maintaining core business. The Gaithersburg site is a highly regulated facility and is developing into a center of excellence for bag manufacturing and critical application single-use assemblies. As the final product has high end use criticality and direct patient impact (gene therapy, cell therapy and final fill biopharmaceutical applications), the incumbent must be able to work on complex problems in which analysis of situations and end-use application is considered.
Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.