Senior Process Engineer

About this role

Career Category Engineering Job Description HOW MIGHT YOU DEFY IMAGINATION?  

You’ve   worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills,   experience   and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over   10 million patients   worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.  

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen   FleX   Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The   FleX   Batch facility not only feature s   the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it also integrate s   sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company .  

Senior Process Engineer  

Live  

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 .   This role will develop domain   expertise   and system ownership   to support   process   operations, focusing on   Downstream Process engineering.  

Responsibilities include:  

• 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.  

• Effectively collaborate with key customers and support groups ( e.g.   Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations.  

• 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.  

• Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations.  

• Provide technical mastery and problem-solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems.  

• Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the   process   equipment.   

• Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments,   identifying   gaps and owning their remediation, implementing equipment modifications, and supporting engineering runs .  

Win  

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  2   years of Engineering experience  

OR  

Bachelor’s degree and  4   years of Engineering experience  

OR  

Associate’s degree and  8   years of Engineering experience  

Or  

High school diploma / GED and   10 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   with a focus on   Downstream   unit operations  

• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration as well as other equipment 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 project

Similar jobs

• Senior Process Engineer — Voyagertechnologiesinc · Pueblo, CO
• Senior Process Engineer — Dukeenergy · Edwardsport, IN
• Senior Process Engineer — FLIR · US - Milpitas, CA
• Senior Process Engineer — Ingredion · Bedford Park, IL
• Senior Process Engineer — Tarkett · Florence (AL), United States | (AL), Huntsville, United States
• Senior Process Engineer — TTM · Salem, NH
• Senior Process Engineer — Promachbuilt · Waukesha, WI
• Senior Process Engineer — Ingredion · South Sioux City, NE