Senior Process Engineer - Solution Prep, Upstream, and Downstream

Career Category

Engineering

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.

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 will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior   Process   Engineer    -   Solution Prep,   Upstream ,   and   Downstream  

What you   will do  

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   Solution Prep,   Upstream ,   and   Downstream   Process engineering and plant equipment .  

Site design, construction, start-up, and operational readiness:  

• S upport the   design and   build   of manufacturing   equipment   systems by   aligning   design review   processes   and documents   with site requirements , including equipment design and sizing, architecture and electrical   distribution, and piping and instrumentation diagrams.    

• S upport   factory   acceptance   testing   working in partnership   with global engineering   during   site   installation ,   including reviewing protocols   and   resolving punch list items .   

• Work with   capital   project team   to e nsure systems are installed and   operating   safely   and   comply with   pertinent environmental health/safety practice,   rules   and regulations   as well as Amgen global engineering requirements .   Ensure   that systems are installed per the design   requirements .    

• Execute   and guide   the commissioning and validation   of systems   to ensure their operational capability   is aligned   with   manufacturing requirements and   GMP   regulation   and on-time project delivery.   Support   execution of engineering and performance qualification runs   while providing   hypercare   support as needed.  

• P erform engineering assessments   for plant equipment operations ,   implementing equipment modifications, and supporting engineering runs   in support of new product/technology introductions as   required .  

Site O perations:  

• Responsible system owner   for   Solution Prep,   Upstream ,   and   Downstream   Drug substance   process equipment , areas, and systems providing   end-to-end   support for operations .  

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

• Work with original equipment manufacturers for breakdown and planned maintenance of   process equipment   as applicable .  

• Lead   identifying   and implementing engineering-based improvements or upgrades to   process   equipment   systems.   This may include developing business cases for improvements,   identifying   design requirements, and translating these requirements into   process   equipment/system design, specifications, and supporting the construction, startup, and validation of equipment.  

• Develop   master   maintenance programs   for equipment , ensure the availability of spare parts, and   coordinate maintenance activities to ensure systems are in proper working order.  

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

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

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

• Provide rotational on-call support and/or shift support based on business needs to ensure   24x7 day-to-day   reliability of Solution Prep, Upstream and Downstream systems   for plant operations.  

• On-site and u p to   10% domestic/international travel .  

​

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:  

• D egree in Chemical or Mechanical Engineering   or similar engineering discipline .  

• 6+   years'   of relevant work experience with 5+ years' experience in Biopharmaceutical   operations/manufacturing environment  

• D irect knowledge of design and troubleshooting with GMP Biopharmaceutical Production   facility equipment/systems   with direct experience with   Solution Prep,   Upstream ,   and    Downstream   purification equipment such   as   weigh and dispense equipment, solution preparation vessels,   cell culture reactors, centrifugation, chromatography,   vi ral   f iltration skids,   and   UFDF   skids   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.  

• Experience with Tech Transfer, Process Design, and Commissioning & Qualification.  

• 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  

• Understanding of   safety requirements working in a GMP Biopharmaceutical   p roduction   facility.  

• Independent, ambitious, organized, able to multi-task in project environments, and skilled in   communication, facilitation, and teamwork .  

• Strong leadership, technical writing, and communication/presentation skills  

• Work schedule flexibility as   required   to support 24/7 operations .  

• Ability for domestic/international travel .  

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team!

careers.amgen.com

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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

115,494.60USD -156,257.40 USD