17 days old

PharmBIO Process Engineer

W.L. Gore
Elkton, Maryland 21921
  • Job Type
    Employee
  • Job Status
    Full Time

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: In a highly regulated industry marked by economic pressures and drug development and processing challenges, Gore provides technology-driven products and process components designed for efficiency, reliability and contamination control. Learn more at gore.com/products/industries

About the Role: We are looking for a Process Engineer to join our Drug Delivery and Packaging PharmBIO Business Unit. In this unique Product Quality focused Process Engineering role, you will ensure product quality across the supply chain by driving risk-based decisions on commercial product in accordance with ISO13485 and ISO15378.  In this rapidly scaling, opportunity-rich environment, you can expect the work to be challenging yet exciting.

This role will be located Elk Mills 2 facility in Elkton, Maryland. This position also is 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.

Responsibilities:
  • Assure product quality across the supply chain by evaluating non-conforming material, identifying and resolving quality issues, and driving process/product changes
  • Work independently as well as cross functionally, to build a strong working relationship across various disciplines (Manufacturing, Quality, Product Specialists, Technical, Leadership, etc.)
  • Partner cross-functionally, both internally and externally, to understand fitness-for-use requirements, drive design changes and/or specification development of derivative products
  • Evaluate, select, validate, and sustain components and materials from various potential supply sources 
  • Drive risk-based decision making based on deep technical and historical knowledge
  • Identify and monitor key product performance measures and driving improvement
  • Develop and validate test methods and fixtures to evaluate product designs and raw materials 
  • On-going support of test methods and products, and develop visual standards and sampling plans
  • Design, execute, and analyze experiments based on statistical techniques
  • Document work via reports, technology notebooks, and the quality system

Requirements

Required Qualifications: 

  • Bachelor's degree in engineering or science with a minimum of 3 years of professional experience post-graduation
  • Experience with hands-on product, test method, process or equipment validations and ability to apply statistical analysis to specification development, validations, sampling plans, quality claims, product improvements, and/or troubleshooting
  • Experience working within a quality system (for example, product surveillance, assessing product complaints, non-conformance, CAPA, change management, field events, risk management, audits, complaints, etc.)
  • Solid knowledge of engineering fundamentals and demonstrated ability to apply them to development, optimization, and troubleshooting activities
  • Ability to establish priorities in an ambiguous, dynamic environment in order to plan and drive multiple projects concurrently from development to completion utilizing project management best practices 
  • Ability to successfully interact with cross-functional teams, communicate effectively and influence others as well as work independently
  • Ability to build depth in product knowledge across the supply chain to drive and support product risk management in partnership with Product Specialist
  • Ability to identify critical issues and failure modes across the supply chain, creating a framework of action to address these issues, assess root cause and improve product/process performance, utilizing effective risk-based decision making
  • Ability to provide off-shift support during certain situations
  • Ability to travel up to 10%

Desired Qualifications:

  • Ability to mentor and coach associates to achieve business results and develop skills
  • Experience transitioning new products to manufacturing
  • A background in the medical device or pharmaceutical industry

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.)

Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

Categories

Posted: 2022-05-05 Expires: 2022-06-04

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PharmBIO Process Engineer

W.L. Gore
Elkton, Maryland 21921

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