Reference : USA00668

Quality Engineer - Bioprocess Solutions, Life Sciences

  • Technical Production
  • United States GAITHERSBURG
  • Permanent / Regular
  • Posting date : 03/31/2022

Position description

If you want to reshape the world and discover your greatest potential, Saint-Gobain provides one-of-a-kind opportunities for innovative problem solvers.

We're one of only two companies in the world that is consistently recognized as both a top Global Employer and a Top 100 Global Innovator, but Saint-Gobain's remarkable story and culture of innovation begins with a team of nearly 200,000 creative, diverse and passionate team members collaborating across the globe. We are committed to our mission to improve lives because, every day, we witness the enormous impact of our efforts on the world around us.

The Quality Engineer will be responsible for ensuring that the quality standards of the company are maintained within the SGPPL Gaithersburg procedures, policies, purchased components and manufactured products through appropriate audit, process development, validation and test activities. Interacts with multiple cross-functional departments, customers, suppliers, and experts outside of Saint-Gobain to implement Saint-Gobain quality objectives and drive continuous improvement. Supports development of procedures, specifications, and standards for Saint-Gobain product and processes. Leads complaint and non-conformance investigations to determine root cause and development of effective corrective and preventive actions. Provides validation support by writing protocols, analyzing data and writing reports. Collects and analyzes data to ensure the quality system is in compliance with standards and regulations. Has basic knowledge of ISO 13485, quality systems, design control, verification and validation, FMEA, product test methods and bel able to provide guidance to others. Participation in third part audits and conducting training as necessary. Takes the initiative to improve the quality operations and to improve and maintain a quality culture with a goal of consistency. 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

- Performing Internal Audits

- Training program; conduct training when needed

- Implementation of Quality Risk Management in relevant aspects of the QMS Support the oversight of product realization and commercial manufacturing activities, such as 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.

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

REQUIRED QUALIFICATIONS

Education

• A Bachelors degree in Engineering is required.

Work Experience

• 2 years of 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) is required.

• 1 year of experience in a quality role (Quality System development, implementation, and/or execution) within a manufacturing environment is required.

Technical Experience

• 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.

• 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.

• A valid drivers license is required.

Who are we ?

Saint-Gobain’s innovations touch almost every major industry around the world. Within its Life Sciences division, teams are solving critical problems for customers who are getting life-saving medical devices to the frontlines of healthcare, discovering essential medications, and nourishing and connecting the world through consumer, industrial and electronics applications. As one of the world’s leading producers of high-performance polymer products, we improve lives by making simple experiences better and being there in life’s critical moments.

Our team members recognize that we all create the environment for people to succeed, with a culture built on respect, open and honest communication, and honoring our commitments to our customers and each other. And at the heart of our culture, we’ve learned working together makes good ideas, great ones.

With a legacy dating back more than 350 years, Saint-Gobain offers employees the stability and security of a leading Global 500 corporation while operating like multiple small and agile start-ups, where entrepreneurial spirit, pioneering teamwork, and bold, forward-thinking ideas pave new paths.

Every team member is encouraged to develop and leverage their unique expertise and strengths to make the greatest impact on the company and our end users. At Saint-Gobain, you’re empowered and equipped with countless opportunities and resources for professional development. You will find the support you need to create a vision and roadmap for your career, and make that vision a reality.

Invent yourself at Saint-Gobain Life Sciences; and together, we’ll create a better life.

Legal Statement

Top employer 2022