Job Description

• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Provide support of senior staff for delivery of Projects.
• Coordinate test method development and delivery with selected contractors and vendors.
• Ensure that qualification parameters are met for product requirements.
• Generate procedures necessary to support department and new process equipment.
• Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals.
• Participate in and assume responsibilities of team functions as assigned – i.e. subject matter experts for test equipment
• Generate/author and own the Test Method documents: Procedures, engineering drawings, specifications, protocols, reports, etc.
• 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.
• Communicate and collaborate internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects.
• Network with manufacturing, quality and regulatory organizations both internal and external to client
  

• Technical writing experience - 1-3 years of experience
• Engineering - 1-3 experience
• New grads considered - BS at minimum (engineering, mechanical, biomed)
• Excellent verbal/written communication skills.
• Solids works, CAD, required
• PLUS - Qualification and validation, and/or statistical experience

• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Provide support of senior staff for delivery of Projects.
• Coordinate test method development and delivery with selected contractors and vendors.
• Ensure that qualification parameters are met for product requirements.
• Generate procedures necessary to support department and new process equipment.
• Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals.
• Participate in and assume responsibilities of team functions as assigned – i.e. subject matter experts for test equipment
• Generate/author and own the Test Method documents: Procedures, engineering drawings, specifications, protocols, reports, etc.
• 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.
• Communicate and collaborate internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects.
• Network with manufacturing, quality and regulatory organizations both internal and external to client.
• Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership
  

• Large periods of unemployment
• No degree in engineering or science
• Does not work well in teams.
• No experience with Solidworks and CAD