Engineer - F&E Environmental & Contamination Control

Join Amgen's Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Engineer, F&E Environmental & Contamination Control What you will do Lets do this. Lets change the world. In this vital role you will report to the Facilities & Engineering organization and serve as a technical deviation owner or Functional area owner responsible for investigating and resolving equipment, utility, automation, facility, commissioning, qualification, and project-related quality events. The Engineering Deviation Owner and/or functional area owner is accountable for the end-to-end management of assigned deviation records, ensuring investigations are technically sound, scientifically justified, inspection-ready, and completed in accordance with site procedures and regulatory expectations. Responsibilities Deviation Ownership & Execution Demonstrated technical writer capable of translating complex engineering, equipment, automation, utility, and project-related events into concise, technically accurate, and inspection-ready documentation. Independently drive deviation investigations from initiation through closure while ensuring compliance with site procedures and quality system requirements. Maintain accountability for record quality, data integrity, technical accuracy, and timely progression of assigned deviations. Prioritize and manage multiple investigations simultaneously in a dynamic manufacturing environment. Technical Investigation & Root Cause Analysis Develop and execute investigation strategies for equipment, utility, facility, automation, commissioning, qualification, and manufacturing support events. Conduct field assessments, equipment walkdowns, system reviews, and Genba activities to gather factual evidence. Utilize engineering problem-solving methodologies to determine root cause and contributing factors. Lead structured Root Cause Analysis (RCA) sessions involving cross-functional stakeholders. Evaluate potential impacts to validated systems, product quality, operational reliability, and compliance. Corrective and Preventive Actions (CAPA) Develop technically robust corrective and preventive actions aligned with investigation outcomes. Ensure CAPAs address both immediate causes and systemic contributors. Support effectiveness verification activities and long-term monitoring strategies. Identify opportunities to improve equipment reliability, utility performance, maintenance practices, and engineering processes. Cross-Functional Collaboration Partner with Manufacturing, Quality Assurance, Quality Control, Automation, Maintenance, Facilities, Engineering Technical Authorities (ETA), Process Development, Capital Projects, and Global Engineering organizations. Facilitate alignment among stakeholders and drive timely technical decision-making. Ensure appropriate SME engagement and challenge assumptions through data-driven discussions. Documentation & Technical Decision Making Develop investigation narratives and technical assessments that clearly communicate event chronology, causal analysis, risk assessments, and conclusions. Support impact assessments associated with: Equipment modifications Utility system changes Automation updates Commissioning and qualification activities Capital project implementation Ensure documentation meets Quality Management System (QMS) requirements and inspection expectations. Regulatory & Inspection Readiness Serve as a Subject Matter Expert (SME) during regulatory inspections and internal audits for assigned investigations. Defend technical conclusions, investigation rationale, and risk-based decisions. Support inspection preparation activities and response development as needed. Data Analysis & Continuous Improvement Analyze deviation trends associated with: Equipment reliability Utility performance Automation systems Facility infrastructure Commissioning and qualification activities Identify recurring issues and opportunities for systemic improvement. Leverage digital tools, data analytics, AI-enabled technologies, and engineering metrics to improve investigation efficiency and effectiveness. Contribute to site initiatives focused on reliability, operational excellence, and inspection readiness. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a self-starter with these qualifications. Basic Qualifications High school diploma / GED and 8 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience OR Associate's degree and 6 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience OR Bachelor's degree and 2 years of Engineering, Facilities, Manufacturing, Automation, CQV, Quality, or related experience OR Master's degree Preferred Qualifications BS/BA in Engineering, Life Sciences, Biotechnology, Chemistry, or related discipline 4+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments Experience with: Facilities & Engineering systems Equipment troubleshooting Utility systems Automation systems (DeltaV, BAS, PI) Commissioning & Qualification (C&Q) Root Cause Analysis methodologies Change Control and Quality Systems Strong technical writing and analytical problem-solving skills Ability to influence and lead cross-functional teams without direct authority Experience applying AI, analytics, or digital tools to support investigations and continuous improvement What you can expect of us As 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, well 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. Equal Opportunity Employer Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr Initial Therapeutics, Inc.