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.

Responsibilities

• 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

• 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

• Lead CAPA identification and development aligned with investigation outcomes

• Support CAPA and Effectiveness Verification (EV) management activities

• 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

• 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

• 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

• 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 ofmanufacturing and/or operations experience

• Associatedegree and 2 years ofmanufacturing and/or operations experience

• Bachelordegree and 6 months of manufacturing and/or operations experience

• MasterdegreeOR

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, we27ll 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.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

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Salary Range