PharmBIO Process Engineer - Quality Focused

We are looking for a quality-focused Process Engineer to join our PharmBIO Rolled Goods Process Engineering Team in EM2 (Elkton, Maryland) with at least 3 years of engineering experience. The primary focus will be to develop systems and approaches to drive excellence in lot-release, process monitoring, and SPC processes supporting existing production lines in Life Sciences Venting (LSV) and Filtration Media (FM). LSV and FM provide roll goods or die cut parts to medical device and pharma processing customers and have more than 15 years of successful and profitable history. The team is focusing on operational excellence and aggressive growth including complementary materials and new applications.

In this role, you will take a proactive, strategic approach to improving our manufacturing processes. You will identify and close gaps in documentation, training, and monitoring systems by deeply understanding our operations from end to end. Partnering closely with manufacturing, quality, and engineering teams, you will develop and implement tools, procedures, and process aids that enhance efficiency, while ensuring a safe and cost-effective work environment within a regulated quality system. Your work will include developing and maintaining clear, standardized training programs, while also analyzing performance and process data to anticipate improvement opportunities and drive sustainable, measurable change within a regulated environment.

This position will be located at our facility in Elkton, Maryland, with the possibility of a hybrid remote work arrangement.

Pay and Benefits:

• $92,000 - $142,000 per year
• Factors considered in extending an offer within this pay range include (but not limited to) education, experience, knowledge, skills, and abilities.
• Medical, Dental and Vision benefits effective on Day 1 of employment! We offer a comprehensive total rewards package, including competitive benefits. More details are available at www.gore.com/careers/benefits

• Develop and execute strategy to maintain accurate equipment documentation and records, ensuring ECLs, Adept, and Agile Quality systems reflect current component details, drawings, and supply information
• Develop and sustain standardized operator training, recertification, and supporting materials to minimize variability and improve manufacturing consistency
• Create and implement manufacturing aids, troubleshooting guides, and process documentation to reduce downtime, support efficient operations, and enable smooth knowledge transfer
• Optimize process monitoring systems, and transition of ownership to manufacturing
• Analyze performance and process data (proactively and upon request) to identify root causes, share insights with engineering teams, and drive continuous improvement
• Improve scrap reporting accuracy by building infrastructure, SOPs, and training materials that align with LDM metrics and quality system requirements
• Review existing manufacturing systems, identify improvement opportunities, and implement/document sustainable changes that enhance efficiency and safety
• Provide day-to-day process support for the manufacturing (i.e lot release, testing, process monitoring) of existing products and transition of new products and processes into manufacturing
• Plan and execute technical work using statistical techniques including Design of Experiments (DoE) and Statistical Process Control (SPC)
• Utilize Gore project practices and GBS/lean tools to effectively prioritize, plan, and drive a wide range of process projects throughout the development cycle: development, scale-up, validation, and improvement (improved safety, cost, quality, capability, and capacity)

• Bachelor of Science Degree in Engineering (or equivalent) with a minimum of 3 years hands-on engineering experience in a manufacturing environment post-graduation
• Experience with designing, implementing methods, and analyzing trends for statistical process control, process improvement, testing and/or inspection (for example - design of experiments (DOE), validation (IQ/OQ/POQ/PQ), & SPC/SQC)
• Demonstrated ability to document, communicate, and present technical bodies of work incuding clear work instructions, SOPs, and support materials
• Demonstrated ability to leverage critical thinking to identify issues and failure modes, creating a framework of action to address these issues and assess root cause or improve product performance
• Ability to prioritize, plan, and independently drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables with a proactive, solution-oriented work style
• Ability to actively listen to feedback, understand and internalize insights, and translate them for effective outcomes (both technical and teaming topics)
• Ability to effectively interact with, influence, and communicate to cross-functional teams, as well as work independently
• Ability to understand interactions between process, equipment, materials, product, and final application
• Ability to make risk-based decisions (for example, use of tools such as FMEA or contingency planning)
• Solid knowledge of manufacturing processes, process monitoring systems, and engineering fundamentals, with demonstrated ability to apply them to documentation, optimization, and troubleshooting activities
• Ability to travel periodically up to 15% and ability to leverage virtual global teaming

• A minimum of 5 years experience and experience working within a regulated quality system such as medical device or pharmaceutical manufacturing with a sound knowledge of medical device industry and its quality standards
• Experience developing and maintaining training programs, manufacturing aids, and process documentation in a regulated quality system environment
• Hands-on experience with product, process, or equipment validations and automation of manufacturing or testing methods

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.