Associate Manufacturing Downstream Operations
6 days ago
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. 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.
Associate Manufacturing Downstream Operations
What you will doLet's do this. Let's change the world. In this vital role you will support the manufacturing of life-changing therapies at Amgen Manufacturing Limited in Puerto Rico. You'll be part of a 24x7 operation, ensuring safe and efficient production through equipment operation, procedural compliance, and teamwork—on any shift, any day, where your contribution makes a difference.
- Operate manufacturing equipment independently after completing required training and qualification.
- Complete and review documentation (e.g., equipment logs, batch records, area audits) in accordance with procedures to ensure compliance.
- Monitor equipment, workspaces, and outputs to meet safety, quality, and performance standards.
- Follow SOPs, cGMPs, and safety protocols using reader-doer or similar methods.
- Record activities, track materials, and verify data using systems like SAP, Symphony, SCADA, or batch record platforms (training provided).
- Apply Good Documentation Practices (GDP) to ensure timely, accurate, and audit-ready records.
- Stay current with SOPs and seek clarification when needed to ensure task accuracy.
- Identify and escalate equipment or process deviations per SOPs.
- Train team members on hands-on tasks to support skill development.
- Support investigations and root-cause analyses to resolve issues and improve processes.
- Collaborate with peers, leads, and trainers to meet goals and maintain a team-oriented culture.
- Adapt to changing priorities and assist during downtime to sustain workflow.
- Participate in daily meetings and use communication tools to align with production needs.
- Demonstrate flexibility, attention to detail, and commitment in a dynamic, 24/7 environment.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Associate Manufacturing professional we seek is an individual contributor with these qualifications.
Basic Qualifications:
- High school/GED + 2 years of Manufacturing experience OR
- Associate's + 6 months of Manufacturing experience OR
- Bachelor's degree
Preferred Qualifications:
- Educational background in Life Sciences, Biotechnology, Engineering, or a related field.
- Willingness to work non-standard or rotating shifts, including weekends.
- Experience in GMP-regulated environments such as biotechnology, pharmaceutical, or medical device industries.
- Skilled in equipment assembly, disassembly, operation, and troubleshooting per SOPs.
- Familiar with systems like Microsoft Office, SAP, MES, and LIMS.
- Strong organizational skills with keen attention to detail.
- Ability to follow procedures, identify malfunctions, and adjust equipment as needed.
- Knowledge of aseptic techniques and cleanroom protocols.
- Effective problem-solving, communication, and teamwork abilities.
- Proficient in technical writing and documentation.
What you can expect of us
As 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.
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.
Sponsorship
Sponsorship for this role is not guaranteed.
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