Senior Associate Manufacturing Deviation Owner Environmental and Contamination Control

Sr Associate Manufacturing Deviation Owner Environmental & Contamination Control

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.

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.

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

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

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 great teammate with these qualifications.

Basic Qualifications

• 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 OR

Preferred Qualifications

• The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education and experience or the equivalent
• 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

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, 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.

Salary Range

86,048.05USD -116,417.95 USD