Job Description

• 3D Design in CAD, SolidWorks.
• Technical Writing Skills.
• Qualification or Validation Experience with equipment, systems, software.

• 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 expert 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 expert 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 own 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
• Comply with the requirements, responsibilities, and authority as required
• Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals
• Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects
• Networks with manufacturing, quality and regulatory organizations both internal and external to client
• Drives the cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle
• Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership
• Collaborates with other functional leaders to ensure project success, momentum and commitment
• Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
• Integrates partner/vendor timelines with client timelines as appropriate

• No B.S. in Mechanical Engineering, Chemical or Biomedical Engineering, or Materials Science.
• No 3D Design Software, CAD, SolidWorks.
• No technical writing skills.
• No communication skills.