Process Engineer - Solution Preparation
Amgen
Holly Springs, North Carolina
Full-Time
Competitive
OfficeExecutive
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 youwill do
In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team tosupport thedesign, build, commissioning, and qualification ofnew equipment and systems needed for drug substance production as well as developing domain expertise tosupport operations upon start up, focusing onSolution Preparationprocess equipment.
Sitedesign,construction, start-up, and operational readiness:
Participate in ongoing FATs as well as SATs and continuethat supportduring installation,commissioningand qualification activities ofSolution Preparationequipmentin alignment with GMP requirements.
Ensure systems are installed and operatingsafetyandcomplywithpertinentenvironmental health/safetypractice,rulesand regulations.
Support water runs, engineering runs, and process qualification activitiesforSolution Preparationequipment.
Work withexistingplantteam, includingmanufacturing,engineering, andmaintenance, to support allmanufacturing and maintenance procedures, associated job plans, and applylessons learned to new plant.
Site Operations:
Provide systemownership andsupportforSolution PreparationBiopharmaceutical process equipmenttypically used inbiologicsmanufacturing (e.g.Single-use Mixers,Downflow Boothes,Scales,StainlessPrep/Hold Vessels,CIP Skidsetc.)
Assistinidentifyingand implementing engineering-based improvements or upgrades to equipmentand unit operationreliabilityby partnering with cross-functional teams.This may includedevelopment ofbusiness cases for improvements,identifyingdesign requirements, translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
Execute master maintenance program (MMP)toensure the availability of spareparts andcoordinating maintenance activities to ensure systems are in proper working orderin partnership with OEMs.
Provide technical support to troubleshoot,identifyand resolve process and system issues as needed.
Provideproblem solving support to reduce production downtime. Thisincludessupporting technical root cause analysis and implementation of corrective/preventiveactions.
Assistwithnew product/technology introductions by performing engineeringand facility fitassessments,implementing equipment modifications, and supporting engineering runs.
Communicatewithsupervisorand support stafftohighlight issues and proposesolutions.
Ensure24x7 day-to-dayreliabilityfor manufacturing operationsforSolution Preparationequipment.
Participate in rotational on-call support onceplantis operational.
What we expectofyou
We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys 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 operations/manufacturing environment
Direct knowledge of biopharmaceutical production facility with direct experience withSolution PreparationProduction(Single-use Mixers, Downflow Boothes, Scales, Stainless Prep/Hold Vessels, etc.), and CIP/SIPSkids.
Ability to analyze problems, develop and propose engineering solutions in a scientificmanner using >
.Salary Range
115,494.60USD -156,257.40 USD