Senior Engineer Confipen Platform and Lifecycle Management

Amgen • New Albany, OH

2d • Onsite

About The Position

Join 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. 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. J ob 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.

Requirements

• 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
• 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed