BioSpace
Overview
Be part of Amgen's mission of serving patients. At Amgen, our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we have helped pioneer biotech in our fight against the world's toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you will help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines. Be part of Amgen's newest and most advanced drug substance manufacturing plant. The FleX Batch facility will combine disposable technologies with traditional stainless-steel equipment to maximize flexibility in operations, feature best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities, and integrate sustainability innovations to reduce carbon and waste as part of Amgen's plan to be a carbon-neutral company by 2027. Role
Downstream Process Engineer What You Will Do
In this role the Engineer reports to the Senior Manager of the Process Engineering group. The position provides daily engineering support at the Amgen North Carolina site. Specific duties include: Provide system ownership for process systems and equipment supporting operations at the site. Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems. Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity; lead the development of a business case if required to support the project. Develop equipment/instrument maintenance programs, ensure spare parts availability, and coordinate maintenance execution to keep systems in proper working order. Ensure systems are installed and operating safely and compliant with environmental health and safety regulations. Ensure commissioning and qualification of systems aligns with GMP requirements and interact with regulatory inspectors as necessary. Apply basic engineering principles to support daily operation, maintenance, and troubleshooting of plant systems. Monitor systems to identify performance risks and implement risk reduction strategies. Provide troubleshooting support to reduce production downtime, including leading or supporting root cause analysis and corrective/preventive actions. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Advance condition-based and predictive maintenance practices by incorporating advanced data analytics where applicable. Own investigations of abnormal conditions through Deviation and related processes. Develop, coordinate, analyze, and present results for operational issues and engineering projects. Provide technical support to commercial and clinical manufacturing as needed, specific to process control and equipment. Collaborate with manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements. Communicate with supervisor and support staff, highlighting issues and proposing solutions. Work in a small group of engineers and/or technicians on ongoing or project-based work. Provide technical support and issue resolution with 24x7 on-call support of utility systems on a rotational basis (may require after-hours, nights, weekends, and holidays). Lead or participate in design, development, and selection of new systems, instruments, calibration capabilities, and consumable components. Evaluate supplier capabilities and assess new technologies for cost savings, throughput, or other capabilities for Amgen manufacturing. What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is dynamic, flexible, and driven with the following qualifications. Basic Qualifications
High School Diploma / GED and 8 years of Engineering experience OR Associates Degree and 6 years of Engineering experience OR Bachelors Degree and 2 years of Engineering experience OR Masters Degree Preferred Qualifications
Downstream process equipment experience Bachelors degree in Chemical or Mechanical engineering 6+ years of relevant work experience with 5+ years in Biopharmaceutical operations/manufacturing Direct knowledge of design and troubleshooting GMP Biopharmaceutical Production facility utilities (e.g., Pharmaceutical Water, Clean Steam, Clean Air, CIP) and related plant utilities Experience with equipment and facility control systems operation, logic, and troubleshooting Experience in a regulated environment (cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes (change control, non-conformances, CAPAs, qualifications/validation) Strong leadership, technical writing, communication/presentation skills, and ability to work with minimal direction Demonstrated interpersonal and facilitation skills; ability to work in a collaborative team-based environment Analytical ability to evaluate and interpret complex problems using multiple information sources Ability to work in cross-functional teams and embrace a team-based environment Experience applying engineering principles to design and implement system modifications, process introductions, and capital project execution Understanding of capital project execution in a GMP Biopharmaceutical facility (procurement, construction, startup, validation) Understanding of safety requirements in a GMP Biopharmaceutical facility Independent, organized, able to multi-task in project environments; strong communication, facilitation, and teamwork Willingness to work flexible hours to support 24/7 operations What You Can Expect Of Us
We support your professional and personal growth and well-being with competitive benefits and a collaborative culture. In addition to base salary, Amgen offers competitive Total Rewards Plans aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. Equal Opportunity
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 provide reasonable accommodation 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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Be part of Amgen's mission of serving patients. At Amgen, our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we have helped pioneer biotech in our fight against the world's toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you will help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines. Be part of Amgen's newest and most advanced drug substance manufacturing plant. The FleX Batch facility will combine disposable technologies with traditional stainless-steel equipment to maximize flexibility in operations, feature best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities, and integrate sustainability innovations to reduce carbon and waste as part of Amgen's plan to be a carbon-neutral company by 2027. Role
Downstream Process Engineer What You Will Do
In this role the Engineer reports to the Senior Manager of the Process Engineering group. The position provides daily engineering support at the Amgen North Carolina site. Specific duties include: Provide system ownership for process systems and equipment supporting operations at the site. Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems. Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity; lead the development of a business case if required to support the project. Develop equipment/instrument maintenance programs, ensure spare parts availability, and coordinate maintenance execution to keep systems in proper working order. Ensure systems are installed and operating safely and compliant with environmental health and safety regulations. Ensure commissioning and qualification of systems aligns with GMP requirements and interact with regulatory inspectors as necessary. Apply basic engineering principles to support daily operation, maintenance, and troubleshooting of plant systems. Monitor systems to identify performance risks and implement risk reduction strategies. Provide troubleshooting support to reduce production downtime, including leading or supporting root cause analysis and corrective/preventive actions. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Advance condition-based and predictive maintenance practices by incorporating advanced data analytics where applicable. Own investigations of abnormal conditions through Deviation and related processes. Develop, coordinate, analyze, and present results for operational issues and engineering projects. Provide technical support to commercial and clinical manufacturing as needed, specific to process control and equipment. Collaborate with manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements. Communicate with supervisor and support staff, highlighting issues and proposing solutions. Work in a small group of engineers and/or technicians on ongoing or project-based work. Provide technical support and issue resolution with 24x7 on-call support of utility systems on a rotational basis (may require after-hours, nights, weekends, and holidays). Lead or participate in design, development, and selection of new systems, instruments, calibration capabilities, and consumable components. Evaluate supplier capabilities and assess new technologies for cost savings, throughput, or other capabilities for Amgen manufacturing. What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is dynamic, flexible, and driven with the following qualifications. Basic Qualifications
High School Diploma / GED and 8 years of Engineering experience OR Associates Degree and 6 years of Engineering experience OR Bachelors Degree and 2 years of Engineering experience OR Masters Degree Preferred Qualifications
Downstream process equipment experience Bachelors degree in Chemical or Mechanical engineering 6+ years of relevant work experience with 5+ years in Biopharmaceutical operations/manufacturing Direct knowledge of design and troubleshooting GMP Biopharmaceutical Production facility utilities (e.g., Pharmaceutical Water, Clean Steam, Clean Air, CIP) and related plant utilities Experience with equipment and facility control systems operation, logic, and troubleshooting Experience in a regulated environment (cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes (change control, non-conformances, CAPAs, qualifications/validation) Strong leadership, technical writing, communication/presentation skills, and ability to work with minimal direction Demonstrated interpersonal and facilitation skills; ability to work in a collaborative team-based environment Analytical ability to evaluate and interpret complex problems using multiple information sources Ability to work in cross-functional teams and embrace a team-based environment Experience applying engineering principles to design and implement system modifications, process introductions, and capital project execution Understanding of capital project execution in a GMP Biopharmaceutical facility (procurement, construction, startup, validation) Understanding of safety requirements in a GMP Biopharmaceutical facility Independent, organized, able to multi-task in project environments; strong communication, facilitation, and teamwork Willingness to work flexible hours to support 24/7 operations What You Can Expect Of Us
We support your professional and personal growth and well-being with competitive benefits and a collaborative culture. In addition to base salary, Amgen offers competitive Total Rewards Plans aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. Equal Opportunity
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 provide reasonable accommodation 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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