Senior Associate Manufacturing Deviation Owner Environmental and Contamination Control

Amgen • West Greenwich, RI

3d • $86,048 - $116,418

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. Sr Associate Manufacturing Deviation Owner Environmental & Contamination Control What you will do Let’s do this. Let’s change the world. In this vital role you will be accountable for end-to-end management of assigned deviation records, including investigation, documentation, and resolution, ensuring compliance with site procedures and regulatory expectations.

Requirements

• High school diploma / GED and 4 years of manufacturing and/or operations experience
• Associate’s degree and 2 years of manufacturing and/or operations experience
• Bachelor’s degree and 6 months of manufacturing and/or operations experience
• Master’s degree

Nice To Haves

• BS/BA or equivalent (science/engineering/psychology preferred)
• 2+ years of experience in the pharmaceutical industry
• Experience applying AI or other digital tools to generate insights and streamline workflows

Responsibilities

• Deviation Ownership & Execution: Demonstrated technical writer able to articulate complex events into concise and clear documentation that is inspection ready. Advanced thinker who, with some oversight from management and mentors, is able to structure investigational workflows with cross-functional team members that help drive teams to sound, data-driven conclusions and advance deviation records forward. Serve as the designated owner for deviation records (initial job scope may focus on Environmental and Contamination Control; however, scope can be across manufacturing events). Ensure timely progression and closure of deviations. Maintain accountability for data integrity and completeness of records.
• Investigation & Root Cause Analysis: Define and execute investigation strategy. Conduct shopfloor observations and Gemba activities, including interviews. Develop, schedule, and execute root cause analyses (RCA) and ensure scientific justification of conclusions.
• CAPA Development & Effectiveness: Lead CAPA identification and development aligned with investigation outcomes. Support CAPA and Effectiveness Verification (EV) management activities.
• Cross-Functional Coordination: Work with various organizations across the site and network including the Contamination Control Lead, Contamination Control Network, process specialists, Quality Assurance (QA), QC / microbial experts, Process Development, and Facilities and Engineering. Ensure appropriate functional input into investigations and decisions.
• Documentation & Decision-Making: Advance strategic decision making for deviation documentation updates. Ensure records meet QMS and SOP requirements. Support change control impact assessments where deviations trigger system/process changes.
• Regulatory & Inspection Interface: Act as SME during inspections for assigned deviations. Be prepared to defend investigation rationale and classification decisions. Participate in daily updates / inspector engagements when required.
• Data Analysis & Continuous Improvement: Provide inputs to deviation trending, data analysis for recurring issues. Identify and share opportunities for prevention strategies and contamination control improvements. Leverage AI and digital tools compliantly to streamline investigation processes.

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 where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior