Specialist Manufacturing Deviation Owner Environmental and Contamination Control
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. Specialist 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 responsible 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 10 years of directly related experience OR Associates degree and 8 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Master’s degree and 2 years of directly related experience OR Doctorate degree
Nice To Haves
- BS/BA or equivalent (science/engineering/psychology preferred)
- 8+ years of experience in the pharmaceutical industry
- Experience applying AI or other digital tools to generate insights and streamline workflows
Responsibilities
- Deviation Ownership & Execution: Advanced technical writer who can articulate complex events into concise, clear, and contemporaneous documentation that is inspection ready. Critical thinker who is able to structure investigational workflows with cross-functional team members that help drive teams to sound, data-driven conclusions that 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. Provides mentorship/coaching to more junior deviation owners.
- 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: Drive 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 primary 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 Support: Deviation trending. Data analysis for recurring issues. Identify and help to implement 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
