Amgen
Biopharmaceutical
ProcessEngineer-SolutionPreparation
Neural analysis suggests this role is
optimal for Mid candidates.
“Process Engineer - Solution Preparation at Amgen. Skills: Solution Preparation, Biopharmaceutical manufacturing, Engineering. Support design, build, commissioning, qualification of new equipment. Develop domain expertise to support operations”
What You'll Achieve.
Ensure systems are installed and operating safety; Ensure systems comply with pertinent environmental health/safety practice, rules and regulations; Ensure the availability of spare parts; Ensure systems are in proper working order; Reduce production downtime; Ensure 24x7 day-to-day reliability for manufacturing operations
Industry & Context.
Analyze problems; Develop and propose engineering solutions; Data-driven techniques and analyses; Troubleshoot; Identify and resolve process and system issues; Problem solving support; Root cause analysis
Participate in rotational on-call support, Work schedule flexibility as required to support 24/7 operations, Occasional after hours engineering coverage
What They're Looking For.
Must Have
High School Diploma / GED and 10 years of Engineering experience, Associate’s Degree and 8 years of Engineering experience, Bachelor’s Degree and 4 years of Engineering experience, Master’s Degree and 2 years of Engineering experience, Doctorate Degree
Nice to Have
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 with Solution Preparation Production (Single-use Mixers, Downflow Boothes, Scales, Stainless Prep/Hold Vessels, etc. ), and CIP/SIP Skids, 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 support of capital projects, Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation, Understanding of safety requirements working in a GMP Biopharmaceutical Production facility, Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork, Work schedule flexibility as required to support 24/7 operations, requiring occasional after hours engineering coverage
What You'll Do.
qualification of new equipment
Develop domain expertise to support operations
Focus on Solution Preparation process equipment
Participate in FATs and SATs
Ensure systems installed and operating safely
Comply with environmental health/safety rules
process qualification
Work with plant team to support procedures
Apply lessons learned to new plant
Provide system ownership and support
Assist in identifying and implementing improvements
Partner with cross-functional teams
Develop business cases for improvements
Identify design requirements
Translate requirements into design
Execute master maintenance program
Ensure availability of spare parts
Coordinate maintenance activities
Provide technical support to troubleshoot issues
Identify and resolve process and system issues
Provide problem solving support to reduce downtime
Support technical root cause analysis
Implement corrective/preventive actions
Assist with new product/technology introductions
Perform engineering and facility fit assessments
Implement equipment modifications
Support engineering runs
Communicate with supervisor and support staff
Highlight issues and propose solutions
Ensure 24x7 day-to-day reliability
Participate in rotational on-call support
How You'll Work.
Team & Collaboration
Partner closely with the corporate engineering team; Work with existing plant team, including manufacturing, engineering, and maintenance; Partnering with cross-functional teams; Skilled in communication, facilitation, and teamwork
Communication Scope
Communicate with supervisor and support staff; Skilled in communication
Process & Methodology
Capital projects, Procurement, Construction, Startup, Validation, Multi-task in project environments
Full Job Description
## **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, commissioning, and qualification 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 p
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