Title: Engineer, GMP Physical Test Methods - Hybrid (JP13129) Location: Thousand Oaks, CA Job Description: Job Title: Engineer, GMP Physical Test Methods - Hybrid (JP13129) Location: Thousand Oaks, CA. 91320 (Hybrid) Business Unit: Employment Type: Contract Duration: 18+ months with likely extensions and/or conversion to a permanent position. Rate: $38 - $42/hour W2 Notes: Only qualified candidates need apply. Must be local to Thousand Oaks, CA will work hybrid (typically onsite about twice per week sometimes more) 3 Key Consulting is hiring! We are recruiting an Engineer, GMP Physical Test Methods for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: 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. Top Must Have Skill Sets: - Technical writing experience - Strong communication skills - CAD experience (modeling, designing) - Experience managing their own workload independently Day to Day 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 - Networks with manufacturing, quality and regulatory organizations both internal and external to client - Drives the multi-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 applied 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 increase efficiently - Integrates partner/vendor timelines with client timelines as appropriate Basic Qualifications: Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience Preferred Qualifications: - M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry - Excellent written and verbal communication skills - Ability to work in a highly matrixed team environment - 2 years of experience in the biotechnology/pharmaceutical industry - 2 years of experience in equipment, method, and mechanical design - Technical writing experience - Experience with SolidWorks (or other 3D-CAD software) - Experience with combination products and regulatory requirements - Experience applying Minitab (or other statistical software packages) Why is the Position Open? Supplement additional workload on team Interview Process: - Phone screen - Video conference We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.