Senior Process Engineer - Clean Utilities

Career Category

Engineering

Job Description

Job Description

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 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.

Senior Process Engineer - Clean Utilities

What you will do

Let’s do this. Let’s change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start up.

• Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order.
• Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations.
• Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
• System guidance to identify performance risks and implement risk reduction strategies.
• Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 3 years of Engineering experience

OR

Bachelor’s degree and 5 years of Engineering experience

OR

Associate’s degree and 10 years of Engineering experience

Or

High school diploma / GED and 12 years of Engineering experience

Preferred Qualifications:

• Bachelor’s degree in Chemical or Mechanical Engineering
• 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/ systems needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the oversight of capital projects
• Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
• Understanding of safety re