Principal Engineer, Container Systems R&D

Company: West Pharmaceutical Services, Inc
Location: Exton
Posted on: February 25, 2021

Job Description:

Principal Engineer, Container Systems R&D Requisition ID: 19414 Date: Jan 29, 2021 Location: Exton, Pennsylvania, US Department: R&D Principal Engineer, Container Systems R&D Exton Pennsylvania West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2018 sales of $1.7 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world. Job Summary: The Principal Engineer will be responsible for leading the execution to the development of Pharmaceutical Container Systems in alignment with the overall R&D strategy starting at conceptualization and through development and transfer to manufacturing. The Engineer will be the lead subject matter expert responsible for analyzing new and emerging markets for system definition, appropriate standards and product requirements that can be translated to developing, drafting and validating test methods for container systems. The Engineer will apply these principles to system level characterization of component assemblies utilizing design control methodologies. Essential Duties and Responsibilities:

• Lead collaborations with internal and external team resources to develop new products, testing standards and technologies:
  • Define deliverables, develop timelines, manage resources, and drive strategic projects to completion within budget and on time.
  • Proactively interpret internal/external challenges and recommend best practices to improve products, processes and services that identify and understand customer/user needs and market requirements.
  • Translate customer/user needs into design inputs/specifications of finally assembly container systems to design output.
  • Lead and facilitate product development platforms that will transition new technologies to plant operations and provide ongoing support thru commercialization as applicable.
  • Guide internal designers and external customers on products, processes to solve complex problems using analytical thinking, tools and judgement to identify innovative solutions
  • --Lead the efforts to develop, execute or sign off on design feasibility, design verification, and validation of test methods.
  • Lead root cause investigations with moderate resources to completion.
  • Prepare and present detailed technical reports, research posters/symposiums and applicable design documentation.
  • Promote and carry out continuous research into relevant standards and guidance, testing and processing technology for sub-assembly components and final assembly container systems.
  • Select, manage and leverage external consultants and laboratories when applicable to advance product concepts and research programs
  • Provide subject matter expertise across the organization and ensure alignment with cross-functional stakeholders
  • Work directly with customers to enable effective use of system level characterization work and to enable successful combination product filings
  • Maintains a clean and tidy laboratory environment that is audit-ready at all times
  • Lead and train other team members to accomplish plant and corporate goals while fostering global harmonization.
  • Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules.
  • Exhibit regular, reliable, punctual and predictable attendance.
  • Perform all other duties as required. Education and Experience:
    • Education: Bachelor's in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or Materials Science. Masters or higher preferred.
    • Experience: Minimum 8-10 years of work-related experience Knowledge, Skills and Abilities:
      • Recognized as an expert for sterility assurance testing of container systems in probabilistic (i.e. Vac/Pressure Decay, Dye Ingress) and deterministic (i.e. He Leak, HVLD) methodologies
      • Must have effective problem solving and interpersonal skills .
      • Proficient with design controls, product development, and test method development/validation.
      • Working knowledge of applicable federal and international regulations such as ISO 13485 - Quality Management Systems for Medical Devices. 21CFR Parts 210, 211, and 820 a plus.
      • Extended knowledge of 3D design applications (i.e. Solidworks) and statistical software such as Minitab.
      • Six-sigma greenbelt or blackbelt a plus.
      • Knowledge in Program Management Methodologies a plus Physical and Travel Requirements
        • Must be able to work (25-35%) in a laboratory and/or shop floor environment
        • Must be able to travel (10-20%) to domestic and international customers as well as West manufacturing location as project requirements dictate. West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a disability or special need that requires accommodation, please send an email to peggy.tayloe@westpharma.com . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

Keywords: West Pharmaceutical Services, Inc, Wilmington , Principal Engineer, Container Systems R&D, Other , Exton, Delaware