Aseptic Officer

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. As a member of the Amgen team, you’ll help make a lasting impact on patients’ lives as we research, manufacture, and deliver innovative medicines that 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 they contain, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while advancing your career.

In this vital role you will provide technical leadership and oversight of aseptic operations within a multi‑product drug‑product manufacturing facility. You will be accountable for maintaining compliance with cGMP requirements through robust execution of the aseptic technique and media fill programs and by supporting contamination control initiatives across operations. You will own the Media Program for one of two isolator‑based filling lines, lead observation and training efforts to sustain aseptic compliance, and partner cross‑functionally with Quality, Validation, and Engineering to ensure sterility assurance standards are consistently met.

• Lead the Aseptic Technique Program for the suite, including routine observation of critical operations, data trending, and implementation of corrective and preventive actions (CAPAs).
• Provide coaching and mentoring to operations personnel to strengthen aseptic practices and contamination control awareness.
• Author, review, and maintain aseptic‑related SOPs, reports, and training materials to ensure alignment with current regulatory expectations and site standards.
• Partner closely with Quality Assurance, Validation, and other site Aseptic Officers to ensure consistent execution and knowledge sharing across functions.
• Represent Manufacturing during internal and external inspections, demonstrating robust understanding and control of aseptic practices.

• Lead the Media Fill program supporting the site’s one of two isolator‑based filling lines.
• Author and implement media fill protocols, complete final reports, and perform data trending and risk analysis.
• Partner with Manufacturing, Quality, and Engineering to ensure execution aligns with aseptic process design, batch records, and contamination control strategy.
• Evaluate results, identify opportunities for process or operator improvement, and ensure timely closure of associated investigations and CAPAs.

• Support contamination and cross‑contamination control initiatives and provide aseptic expertise in investigations, deviations, and change controls.
• Participate in data reviews and trending related to aseptic or microbiological quality indicators (e.g., EM, bioburden, or utility monitoring) as needed.
• Contribute to improvements in facility design, procedures, and behaviors that enhance aseptic performance and sterility assurance.
• Participate in partner and regulatory audits, provide required information, and respond to findings as appropriate.

• Actively participate in Lean Transformation and continuous improvement initiatives (e.g., SQDIP boards, Kaizen events, and Work Center Teams).
• Use problem‑solving and root‑cause tools (5S, Fishbone, 5 Whys) to identify and implement improvements to aseptic performance and process control.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go‑getter with the following qualifications.

• Doctorate degree
• Masters degree and 2 years of operations or quality experience
• Bachelors degree and 4 years of operations or quality…