Engineer Principal, Medical Device - Physical Test Methods (JP11208)

Job Title: Engineer Principal, Medical Device - Physical Test Methods (JP11208) Location: Thousand Oaks, CA. 91320 Employment Type: Contract Business Unit: Physical Testing Systems Development Duration: 18+ months with likely extensions and/or conversion to permanent Posting Date: 01/03/2023 Notes : Onsite - Shift/Schedule: Monday - Friday, 7:00am - 4:00pm, 8:00am - 6:00pm (flexible) 3 Key Consulting is hiring an Engineer Principal for a consulting engagement with our direct client, a leading global biopharmaceutical company. Job Description: Reporting to the Director Physical Sciences and Engineering, Manufacturing Sciences and Technology (MSAT), the successful candidate for this position will manage (projects, personnel, and laboratory) an engineering group responsible for development of innovative solutions to complex biotechnology device and packaging problems based on insightful interpretation and analysis of the problem statement or investigation. These key activities serve MSAT in the development of physical methods, characterization studies, and design verification deliverables for CPO. The principal engineer will operate in a highly matrixed environment to collaborate effectively with cross functional teams. The principal engineer is responsible to critically analyze department requirements, ensure documentation and laboratories maintain proper state of qualification, calibration and preparedness for inspections related to safety, compliance and procedures. The principal engineer must also clearly communicate and elevate technical or strategic issues to team members and management as needed and make robust recommendations and/or decisions to guide successful execution of mechanical testing for primary containers, device and packaging test methods. Group members within the functional area look up to this position as a scientific/technical expert who can provide guidance on associated issues as needed. Demonstrated supervisory skillare required. Responsibilities : Own and maintain business processes for development, qualification, validation and transfer of physical test methods for product verification of new products, and transfer of validated methods to company supply chain, Quality, or manufacturing labs at all company sites. The principal engineer must ensure documentation can withstand an audit and pass agency scrutiny. Develop and own Standard Operating Procedures for data creation, storage, retention, and audit in accordance with Title 21 CFR Part 11 Compliance for all lab testing and associated 21CFR 820 requirements for device development. Rapidly design, develop, qualify, and innovate automated inspection equipment for company primary containers and devices to meet new and unique product requirements. Work with Device Technologies to advance state of the art physical methods and other emerging technologies to characterize, evaluate, and release combination products, primary containers, and secondary packaging. The candidate is expected to support input data solutions going into Device Master Records and associated work product with clinical and commercial manufacturing for combination products, primary containers, and secondary packaging. Design, develop and execute mechanical testing using phase appropriate controls for the development and qualification of primary container platforms and medical devices to develop specifications. Facilitate communication with compay sites and vendors to establish user requirements for the characterization of primary packaging components used in the commercialization of drug products and devices Work closely with facilities, maintenance, instrumentation, and electrical systems to ensure laboratory equipment is maintained in compliance with all industry, regulatory, corporate, and regulatory standards. Ensure laboratory compliance for quality audits utilizing internal and external calibration laboratories, vendors and suppliers. Advise others on methods of resolving measurement problems. Keep current with information from other industry experts through participation in government and industrial standardization committees and professional societies Basic Qualification Doctorate degree and 2 years of engineering experience OR Master's degree and 6 years of engineering experience OR Bachelor's degree and 8 years of engineering experience. 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Degree in Engineering, MBA or related field 8+ years of experience with 3+ years' experience in leading a highly matrixed physical characterization metrology laboratory in a highly regulated environment Experience including managing a lean, high performing technical staff for 3+ years, direct experience in optimization of equipment designs, physical methods, statistical design (Six sigma is highly desired), geometric dimensions and tolerances, kinetic modeling, Solid Works engineering drawing, DOE, and DFM tool sets Formal education in project management Excellent problem solving, trouble shooting, and communication skills. Ability to participate in global cross-functional teams and work effectively in a highly matrixed team environment with rapidly evolving challenges Demonstrated competencies skills and proven track record of leading cross-functional projects, ability to coach junior engineers, strong team work, excellent interpersonal and communication skills Experience with MS Office Suite, MS SharePoint, MS Project, Minitab/JMP, SolidWorks Top Must Have Skills: Test Method development/validation experience, Equipment qualification and implementation Experience with regulated industry Pharma, Biotech, preferred Experience with managing projects and teams Masters, PhD degree, Bachelors with minimum 8 years Day to Day Responsibilities: Own and maintain business processes for development, qualification, validation and transfer of physical test methods for product verification of new products, and transfer of validated methods to company supply chain, Quality, or manufacturing labs at all client sites. The principal engineer must ensure documentation can withstand an audit and pass agency scrutiny. Red Flags: No formal engineering training No BS degree Job jumping - multiple job changes within the year Interview process: Phone screen - 30 min Panel interview via Webex. We invite qualified candidates to send your resume to recruiting@ . If you decide that you're not interested in pursuing this position, please feel free to take a look at the other positions on our website /careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role. Regards,3KC Talent Acquisition Team

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