Amgen
Holly Springs, NC
Shift: Full time
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. Process Engineer - Solution Preparation 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 support the design, build, commission ing , and qualif ication of new equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start up , focusing on Solution Preparation process equipment. Site design, construction, start-up, and operational readiness: P articipate in ongoing FATs as well as SATs and continue that support during installation, commissioning and qualification activities of Solution Preparation equipment in alignment with GMP requirements . Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice , rules and regulations. S upport water runs, engineering runs, and process qualification activities for Solution Preparation equipment. Work with existing plant team, including manufacturing, engineering , and m aintenance, to support all manufacturing and m aintenance procedures, associated job plans, and apply lessons learned to new plant. Site O perations: Provide system ownership and support for Solution Preparation Biopharmaceutical process equipment typically used in biologics manufacturing ( e.g. Single-use Mixers , Downflow Boothes , Scales , Stainless Prep/Hold Vessels, CIP Skids etc. ) Assist in identifying and implementing engineering-based improvements or upgrades to equipment and unit operation re liability by partnering with cross-functional teams . This may include development of business cases for improvements, identifying design requirements, translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment. E xecute master maintenance program (MMP) to ensure the availability of spare parts and coordinating maintenance activities to ensure systems are in proper working order in partnership with OEM s . Provide technical support to troubleshoot, identify and resolve process and system issues as needed. Provid e problem solving support to reduce production downtime. This includes supporting technical root cause analysis and implementation of corrective/preventive action s . Assist with new product/technology introductions by performing engineering and facility fit assessments, implementing equipment modifications, and supporting engineering runs . Communicat e with supervisor and support staff to highlight issues and propos e solutions. Ensure 24x7 day-to-day reliability for manufacturing operations for Solution Preparation equipment . Participate in rotational on-call support once plant is operational . 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: High School Diploma / GED and 10 years of Engineering experience OR Associate’s Degree and 8 years of Engineering experience OR Bachelor’s Degree and 4 years of Engineering experience OR Master’s Degree and 2 years of Engineering experience OR Doctorate Degree Preferred Qualifications: Bachelor’s degree in Chemical or Mechanical Engineering . 6 years of relevant work experience with 5 years experience in Biopharmaceutical operation