Senior Engineer Confipen Platform and Lifecycle Management

Job description

Career CategoryProcess DevelopmentJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let's do this. Let's change the world. In this role, the Sr. Process Development Engineer reports to the Associate Director of Process Development and serves as the technical leader and Subject Matter Expert (SME) for combination products, drug delivery devices, and automated assembly technologies supporting commercial Combination Product and Final Drug Product (FDP) operations at the Amgen Ohio site. Job Details: The senior engineer will lead the design, development, and lifecycle management for commercial Confipen devices and combination products assembly and packaging lines. The scope of the position includes Confipen devices packaging machinery. The qualified candidate will be part of a development and implementation site Process Development engineering team that supports final product assembly and packaging lifecycle process support. These responsibilities include but are not limited to: Advising on combination product requirements and specifications Leading product testing to demonstrate product safety, performance, and efficacy Analyzing data to support design acceptance, performance capability, and failure analysis Creating and executing test protocols and methods Support manufacturing scale-up and NPI launches Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution Leads troubleshooting for assembly, testing and packaging equipment Engaging suppliers and development partners regarding component specifications and quality levels Provides authorship and expert technical leadership for regulatory filings Managing project scope, schedule, and budget Owns and support quality records, change records, and deviations Leads RCA process related to Quality events and device failures to identify corrective actions Interface with Process Development and external partners as a technical subject matter expert. Leads continuous improvement activities Lead troubleshooting activities for line process and machinery Mentor junior engineers and provide technical guidance across multiple engineering disciplines Essential skills and experience: Application of good documentation practice in creation and maintenance of technical design records, including but not limited to design input requirements, design specifications, verification protocols and reports, design transfer plans Proven ability to lead cross-functional teams including scientists, engineers, suppliers, project managers, manufacturing, marketing, regulatory affairs, and quality to enable development efforts Proficiency in the interpretation and application of technical standards (e.g. ASTM, ISO) Capability to use design software (e.g. SolidWorks), create, and interpret engineering drawings Knowledge of statistical methods, such as capability analysis, Design of Experiments, Statistical Process Control Understanding of risk management principles, to be able to support product risk assessment activities Experience leading root cause investigations, design of experiments, coordinate design improvements with development partners, and lead implementation Experience creating and managing project plans Strong written and verbal communication skills This position is located in New Albany, OH and requires up to 10% domestic and international travel. Basic Qualifications: Doctorate degree OR Master’s degree & 2 years of Engineering and/or Operations experience OR Bachelor’s degree & 4 years of Engineering and/or Operations experience OR Associate’s degree & 8 years of Engineering and/or Operations experience OR High school diploma / GED and 10 years of Engineering and/or Operations experience Preferred Qualifications: Bachelor's degree in engineering or other science-related field with 7+ years of relevant work experience with 5+ years of experience in operations/manufacturing environment ≥ 3 years of experience in medical device, pharmaceutical or a similar regulated industry Background in development and commercialization of medical devices, and knowledge of manufacturing processes Understanding of the following standards and regulations:Quality System Regulation – 21CFR820 Quality Management System for medical device/component manufacturers - ISO 13485 Risk Management for Medical Devices – ISO 14971 EU Medical Device Regulation – 2017/745 Excellent communication and technical writing skills Ability to work independently and across functional teams ≥ 3 years of experience in drug containers, drug delivery, or related functions. ≥ 3 years of experience in testing equipment, methods, and mechanical design Project management experience/ Multi-tasker to enable managing multiple deliverables/priorities Proficiency in Solidworks/CAD/Drawings/Assemblies Design for Manufacturing (DFX)/Design for Assembly (DFA) Knowledgeable about Design Controls / Combination Products Knowledgeable about Regulatory Standards and Compendial Requirements Problem solving / Root Cause Analysis Flexible/Highly adaptive to continuous changing priorities/environment Strong team player, interpersonal and communication skills Strong oral and written communication skills, including the ability to coordinate and communicate across different functions and sites in order to successfully complete projects Strong mechanical engineering and material science knowledge What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such