The Engineer, in Physical Methods, is responsible for engineering activities required for the development /
qualification / validation and transfer of physical GMP test methods for combination products, devices,
primary containers, and secondary packaging parts. The Engineer shall have the ability to work on
multiple projects at one time that may involve changes or new product, processes, tooling or equipment
introduction to improve quality and reliability and reduce cost. Phases of projects include: developing
combination product test methods, providing key experienced support for qualification, validation, transfer,
and life cycle support of methods for manufacturing, new product introduction, training, and production
support.
Responsibilities:
• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and
injection devices.
• Work in teams to transfer new combination product test method and assembly
requirements to manufacturing, by developing six sigma processes and compiling
documentation for manufacturing assembly requirements.
• Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
• Implement projects per Final Product Technologies and company procedures to ensure
projects are completed on schedule and within established budget.
• Provide experienced support for investigations as well as new process development
required to improve manufacturing operations.
• Coordinate test method development and delivery with selected contractors.
• Ensure that qualification parameters are met for product assembly requirements.
• Support development of cost estimates for new processes, gauges and equipment
development used in generation of capital request documentation.
• Generate procedures necessary to support department and new process equipment.
• Provide experienced training to individuals in the operation and maintenance of processes,
test methods and equipment introduced to Quality Control and/or the manufacturing
department (i.e. production operator, mechanics, process engineers).
• Participate in and assume responsibilities of team functions as assigned (i.e. Product
Improvement Teams).
• Generate/author and be responsible for the Test Method documents.
Gather test method requirements that result in equipment that operates safely and
considers ergonomic factors in the design
• Perform other duties as required by the Group Manager
• Align with the requirements, responsibilities, and authority as required
• Maintains integrated timelines collecting appropriate multi-functional details and work which
are aligned with the functional and project work
• Networks internally to ensure alignment, commitment to project objectives and timelines as
well as to ensure effective execution of projects
