Job Description

Overview Job Title: Engineer Senior, Physical Test Methods, Drug Delivery Device (JP13325) Location: Thousand Oaks, CA 91320 Business Unit: Physical Testing Systems Development Employment Type: Contract • Duration: 18+ months with possible extension or conversion to FTE Rate: $45 - $50/hour W2 with benefits Posting Date: 10/30/2024 Notes: Monday, Wednesday, Friday (Remote); Tuesday, Thursday (On site) 8am - 5pm (flex) / 7am-4pm 3 Key Consulting is recruiting an Engineer Senior, Validation Physical Test Methods Combination Devices for a consulting engagement with a leading global biotechnology company. Qualifications & Experience Ideal candidate has at least a Bachelor’s degree with substantial professional experience. Targeting at least 4 or more years of related work experience. Preference for experience in the pharmaceutical or medical device industries or other highly regulated environments. Top Must Have Skill Sets: Engineering background (Mechanical, Biomedical, or Manufacturing) Experience with CAD (SolidWorks preferred) & fixture or component design Experience in a regulated field (Medical devices, pharmaceutical, Aerospace, etc.) Job Description & Responsibilities The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products, devices, primary containers, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects simultaneously, involving new or changed products, processes, tooling or equipment to improve product quality and reliability. Day to Day Responsibilities: Ensure transfer of new combination product test methods to QC or manufacturing by developing six sigma processes and compiling all required documentation. Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within budget. Apply core engineering principles to develop physical test methods for medical device and combination product systems. Perform data analysis to support method development, qualification, validation, and transfer. Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes. Support investigations and new processes development to improve manufacturing operations (quality, reliability, new product introduction, cost saving). Coordinate gauge and equipment development and delivery with selected contractors. Ensure qualification parameters are met for product assembly and performance requirements. Support development of cost estimates for new processes, gauges and equipment development used in capital request documentation. Generate procedures to support department and new product equipment. Provide training for operation and maintenance of processes, gauges and equipment in the manufacturing department. Participate in team functions (e.g., Product Improvement Teams) and supervise support staff during development and manufacture of systems. Maintain excellent written and verbal communication and organizational skills. Develop and maintain integrated timelines aligned with functional and project deliverables. Coordinate with manufacturing, quality and regulatory organizations; ensure cross-functional awareness of changes in deliverables and risk. Identify issues/risks and develop mitigation options to resolve or escalate efficiently. Coordinate timelines with partner/vendor activities as appropriate. Basic Qualifications Doctorate Degree OR Master’s Degree and 3 years of Engineering experience OR Bachelor’s Degree and 5 years of Engineering experience OR Associate’s degree and 10 years of Engineering experience OR High school diploma/GED and 12 years of Engineering experience Preferred Qualifications M.S. or Ph.D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering Excellent written and verbal communication skills; ability to work in a matrixed team Experience managing technical teams, including setting priorities and allocating resources Technical writing experience Spanish language skills preferred Experience with SolidWorks (or other 3D-CAD software) Familiarity with equipment and software IOQ Experience with process characterization, scale-up, technology transfer, pFMEAs and dFMEAs Experience with change controls, deviations, CAPA Experience with combination products and device regulatory requirements Understanding of Six Sigma and using Minitab or similar statistical software Experience with cGMPs, regulatory filings and compliance for sterile injectable products Experience with machine controls (PLC, HMI) and vision systems Interview Process Initial phone screening with manager; panel interview with team (video or onsite). Application Qualified candidates may send resume to recruiting@3keyconsulting.com . For other positions, visit #J-18808-Ljbffr 3key Consulting, Inc.

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