Career CategoryManufacturing
Job DescriptionSpecialist Manufacturing - DeviationsWhat you will doLet's do this. Let's change the world. In this vital role you will lead the optimization of critical manufacturing processes, driving innovation and quality that directly impacts the lives of patients around the globe.
Specific responsibilities include but are not limited to:- Serve as the subject matter expert for specific manufacturing processes, equipment, or systems, providing technical leadership across the site.
- Own and maintain SOPs, batch records, and technical documentation to ensure compliance with cGMP and regulatory standards.
- Lead troubleshooting efforts for complex process or equipment issues, conducting root cause analyses and implementing preventive measures.
- Monitor manufacturing data and performance metrics to identify trends, risks, and opportunities for improvement.
- Drive continuous improvement by exploring new technologies, digital tools, and best practices to enhance process efficiency and reliability.
- Provide formal training and mentorship to team members on new or complex manufacturing processes and systems.
- Represent Manufacturing in cross-functional meetings, audits, and investigations, translating technical insights into actionable recommendations.
- Lead or support change controls, deviations, and CAPAs to ensure consistent product quality and regulatory compliance.
- Plan and manage projects related to process optimization, ensuring timely execution and alignment with quality standards.
- Support a culture of accountability, safety, and performance by modeling high standards and reinforcing compliance expectations.
- Guide team members through troubleshooting and process improvement efforts, sharing best practices and lessons learned.
- Stay current on industry trends and technical advancements through continuous learning and external engagement.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Specialist Manufacturing professional we seek is an individual contributor leader with these qualifications.
Basic Qualifications:Doctorate degree
Or
Master's degree and 2 years of Manufacturing Support experience
Or
Bachelor's degree and 4 years of Manufacturing Support experience
Or
Associate's degree and 8 years of Manufacturing Support experience
Or
High school diploma / GED and 10 years of Manufacturing Support experience
Preferred Qualifications:- Advanced experience in Quality Systems, with demonstrated expertise in Major Deviations, CAPA, and CAPA Effectiveness Verification (EV) within a regulated GxP environment.
- Proven ability to lead and own complex root cause investigations, including facilitating RCA discussions and driving cross-functional alignment.
- Proficient technical writing skills with the ability to produce concise, objective, evidence-based, inspection-ready documentation in compliance with ALCOA+ and Good Documentation Practices.
- Strong sense of accountability and ownership, with the ability to manage multiple high-impact deviations simultaneously and deliver timely, compliant outcomes.
- Demonstrated ability to evaluate compliance issues, perform advanced data trending and analysis, and assess systemic quality risks.
- Ability to identify systemic quality signals, recurring failure modes, and cross-functional process vulnerabilities through trend analysis and prior occurrence assessment.
- Experience engaging directly with manufacturing operations, including floor support, process observation, and personnel interviews across multiple shifts.
- Proven experience supporting regulatory inspections and audits, including demonstrated ability to interact with regulatory agencies.
- Technically savvy and adaptable, with openness to leveraging digital tools, automation, and emerging technologies (including AI-enabled tools) to improve investigation effectiveness.
- Flexibility to support variable schedules and cross-time-zone interactions, while consistently demonstrating Amgen Values and Leadership Practices.
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
- 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 and an annual site shutdown
- Flexible work models, including remote work arrangements, where possible
Apply now and make a lasting impact with the Amgen team. careers.amgen.comIn 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.
SponsorshipSponsorship 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.
