| Job Description | Description
Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries, including medical devices, fabrics, electronics, and manufacturing, for more than 50 years. What can you change by joining Gore? Visit gore.com/change-life to find out.
Job Description
Gore PharmBIO Products ensures purity and security for global pharmaceutical and biotechnology manufacturers by developing and supplying innovative, nonreactive product-contact components that control contamination and meet demanding process challenges. We are looking for an experienced Process Engineer to join our team in Elkton, MD.
If you are searching for a company where you can make a difference, we're looking for you. In this role, you will support packaging needs for new and existing products in a cGMP manufacturing environment. You will be responsible for understanding and working within the entire supply chain. Products are manufacturing in a controlled clean-room environment. Responsibilities will include management of the change process and process/product requirements of the quality system using appropriate documentation.
The ideal candidate will:
Be passionate about support packaging needs for products that are the highest quality in their class
Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
Recognize the importance of building and maintaining strong interpersonal relationships
Responsibilities include:
Working with vendors to identify appropriate packaging materials and components
Diagnosing and solving raw material and processing problems
Planning, documenting, and executing packaging, process, and equipment validations in accordance with regulatory and PharmBIO quality system guidelines
Creating, executing, and analyzing experiments using statistical methods
Designing new and improving existing manufacturing packaging processes
Assessing process and product improvements for regulatory, quality, ergonomic, safety, environmental, and cost impacts
Creating procedures and providing training and coaching to technical and manufacturing associates
Developing and executing project plans and milestones to achieve results
Identifying root cause and implementing corrective actions for non-conformances or customer concerns
Working with new-product development to design and specify new packaging materials and methods
Understanding and driving best practices, methods, and appropriate fitness-for-use testing criteria for packaging components, including biocompatibility, sterilization, shelf life, ship tests, product traceability marking, printing, and product information inserts
Qualifications
Required Job Qualifications
Bachelor's degree in engineering
At least 3 years' engineering experience in a manufacturing environment
Fundamental understanding of statistics
Ability to influence and drive consistency with diverse cross-functional global teams
Experience writing technical documents
Ability to travel up to 10%
Desirable Job Qualification
Experience in medical or pharmaceutical manufacturing
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
EEO/AA Employer
Keywords: Gore, PharmBIO, Baltimore, Elkton, Philadelphia, Wilmington, Maryland, MD, Pennsylvania, PA, Delaware, DE, biotechnology, medical, pharmaceutical, technology, technologies, packaging, engineer, engineering, mechanical, industrial, manufacturing, product, process, troubleshooting, designing, designed, specifying, developing, development, implement, experiments, prototypes, testing, biocompatibility, sterilization, shelf life, statistical, analysis, quality, regulated, technical, documentation, documents, writing
Job: Engineer/Scientist
Primary Location: North America-United States-Maryland-Elkton
Travel: Yes, 10% of the time
Shift: Day (1st shift)ý
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| | Company | | W L Gore & Associates Inc | Job Code | | State or Province | | Maryland | | |
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