- Thousand Oaks Blvd, Thousand Oaks, CA, USA
Leading Bio- Pharma client
Onsite M-F 8-5
Ideal candidate- MS in mechanical Engineering, 1-2 years of professional work experience, solid works, technical writing skills, Statistical skills, great problem solving skills. This is an entry level role.
The Engineer will work under the team: Mechanical Engineering Methods. They will be 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 components. The Engineer will have the ability to work on projects that may involve changes or new product, processes, tooling, or equipment introduction to improve quality, reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.
Responsibilities may include:
• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Provide support of senior staff for investigations as well as new process development required to improve manufacturing operations.
• 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
Or Bachelor's Degree and 2 years of engineering/scientific experience
Top 3 Must Have Skill Sets:
4-5 years experience or greater
poor resume design
no professional experience