Process Engineer - PharmBio
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POST DATE 9/8/2016
END DATE 10/9/2016
W.L. Gore & Associates, Inc.
JOB DESCRIPTIONGore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Our diverse portfolio includes everything from high-performance fabrics and implantable medical devices to industrial manufacturing components and aerospace electronics. Through our product leadership, we've been changing lives and changing industries for more than 50 years. What can you change by joining Gore? Visit gore.com/change-life to find out.
Gore PharmBIO Products is committed to satisfying the future product needs and quality initiatives of the highly-regulated industries we serve. Our technologies, capabilities and competencies in fluoropolymer science are uniquely focused on meeting the evolving product and regulatory needs of pharmaceutical and bioprocessing customers, and medical device manufacturers. 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 new and existing processes in a controlled cleanroom manufacturing environment that operates in accordance with ISO13485. Your daily activities will have a direct impact on the quality of our existing products as well as on next-generation products during design and development.
The ideal candidate will:
* Be passionate about manufacturing products that are the highest quality in their class.
* Enjoy the challenge of troubleshooting technically complex product issues.
* Be energized by collaborating on cross-functional teams including manufacturing and development.
* Recognize the importance of building and maintaining strong interpersonal relationships.
* Providing day-to-day process support for the manufacturing of existing products and transition new products and processes into manufacturing
* Applying formal problem-solving techniques to determine root cause, troubleshooting non-conforming products, raw materials, and components, and developing and implementing corrective and preventative action (CAPA) plans
* Understanding product fitness for use and critical process parameters to ensure the process reliability delivers a fit for use product that meets all specifications and customer requirements
* Planning and executing technical work using statistical techniques including Design of Experiments, Evaluating the Measurement Procedure, and Statistical Process Control
Identify opportunities to continuously improving our products and processes and assess for regulatory, quality, ergonomic, safety, environmental, and cost impact * Partnering with design engineers to develop and commission new equipment
* Partnering with Operations team members to evaluate raw material and component suppliers' quality level and conformance to specifications
* Planning and executing product, process and/or equipment validations in accordance with FDA and/or ISO guidelines
* Creating procedures and providing training and coaching to other technical and manufacturing associates
* Driving projects effectively towards completion using Gore project practices
* Using the PharmBIO Quality System to execute, implement, and document work
* Effectively working and influencing within a cross functional team
REQUIRED JOB QUALIFICATIONS:
* Bachelors degree in Engineering
* Minimum of 3 years in a technical engineering role
* Solid knowledge of engineering fundamentals and the proven ability to apply this knowledge in manufacturing and process improvements and new process development
* Demonstrated ability to prioritize, plan, and drive projects to completion using project practices
* Proven ability to:
* Work effectively in team situations as well as independently
* Effectively interact with and influence manufacturing, quality assurance, and regulatory associates, product specialists, and technical and plant leadership, as well as external suppliers
* Work effectively within the Quality System
* Work in a clean-room environment wearing clean-room garments
* Identify potential failure modes and assess root cause
* Ability to concurrently manage multiple products and projects
* Hands-on involvement with all phases of his/her projects
* Ability to appropriately use statistics to analyze data
* Technical problem-solving and critical thinking
* Excellent oral and written communication skills with a proven ability to communicate technical work effectively
* Excellent interpersonal skills, with the proven ability to overcome conflict
* Willingness to travel periodically
DESIRED JOB QUALIFICATIONS:
* Demonstrated capability to sponsor, coach and mentor other technical associates
* Demonstrated success developing followership and leading cross-functional teams in project execution
* Experience with the following tools or techniques: Process Validations, DOE, FMEA, analysis of variance, EMP studies, lean manufacturing, quality function deployment, value stream mapping, and/or 5S techniques
* Experience working within a quality system of a regulated environment
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
Gore requires all applicants to be eligible to work within the US. Gore generally will not sponsor visas unless otherwise noted on the position description.
Gore is a M/F, Disabled and Vet EEO/AA Employer. (Applies to all positions in the U.S.)
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