About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.
About the Industry: Externally focused, disciplined innovation drives Gore to develop new technology and create new products. Combining our materials science expertise with market insights,?we deliver solutions that improve lives — from medical devices that heal patients, to fabrics that protect first responders in the line of duty. Learn more at gore.com/products/industries
About the Role: We are looking for a Clean Room Quality Engineer/Environmental Monitoring & Control (EM&C) Associate who will supportour supply chains that manufacture materials which are ultimately used in products within GORE’s PharmBIO and Medical Device businesses. In this role you will also ensure the environmental quality of GMP and R&D cleanrooms (ISO Class 7, 8 & 9 areas) in support of internal procedures, external standards and audit responses.
This position offers the option to work on-site at our facility in Elkton, Maryland with flexible work from home options available. This position may be eligible for a hybrid work arrangement, meaning you could work remote part of the time, depending upon the responsibilities of the role and business needs.*
Define and execute the strategy for the Environmental Monitoring & Control (EM&C) organization within Core Technology
Lead cleanroom event response through investigation, resolution, documentation and coordination of any needed re-testing as a result of upset conditions (e.g. power outage, spill response, pest control, and crisis support)
Lead and executing projects, including cleanroom validations and continuous improvement projects, including defining project scopes, planning investments and resources, writing documents and procedures
Establish and coordinate external contractors to perform annual testing, certifications, and routine and event-based cleaning
Ensure adequate system controls (policies, procedures, training, etc.) and data integrity (e.g. cleanroom cleaning, and environmental monitoring) for clean-room compliance
Perform periodic environmental monitoring trending reviews and initiating responses as necessary
Collaborate with leadership, manufacturing teams and new product development, to conceptualize, refine, and implement the needed clean room(s), equipment/infrastructure, and procedures
Provide technical expertise and healthy challenge in a collaborative environment
Support EM&C as point of contact in external and internal audits
Strong interest and ability to learn all desired qualifications below
Bachelor degree in engineering or science field
A minimum of 3 years of professional experience post degree
Demonstrated experience leading, initiating and driving projects to completion
Experience working with data and an ability to effectively perform technical analysis (for example data trending and use of statistical analysis)
Experience making risk based decisions
Ability to work within a Quality System as evidenced by experience navigating and adhering to structured system requirements
Demonstrated effective communication of technical information, both verbally and in written reports
Competence influencing a cross-functional team
Ability to prioritize and multitask
Ability and willingness to respond beyond normal business hours (including weekends) for ~ 4 regularly scheduled shut-downs per year, and rare process upsets
Knowledgeable with Environmental Standards (ISO 14644-1, ISO 14644-2, ISO 14698-1, etc.)
Understanding relevant aspects of bioburden, endotoxin, particulate, etc. and conducting statistical analysis thereof
Experience working in a cleanroom environment and/or understanding HVAC facility infrastructure, as it relates to supporting a cleanroom
*Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. Locations not eligible for new remote work arrangements include: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at gore.com/careers
We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
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 U.S. 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.)