BioSpace
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 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’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 lives. Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges, 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 feature best‑in‑class drug substance manufacturing technologies with embedded industry 4.0 capabilities, and will integrate sustainability innovations to reduce carbon and waste as part of Amgen’s plan to be a carbon‑neutral company by 2027.
What You Will Do
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 to the equipment or facility systems. Lead the development of a business case if required to support the completion of the project.
Develop equipment/instrument maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
Ensure systems are installed and operating safely and comply with pertinent environmental health/safety practices, rules and regulations.
Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.
Apply basic engineering principles and practices in support of 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 and/or supporting technical root cause analysis and implementation of corrective/preventive actions.
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
Own investigations of abnormal conditions through deviation and business 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 process equipment.
Work closely with multiple subject areas, including 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 an ongoing or project basis.
Provide technical support and issue resolution with 24x7 on‑call support of utility systems on a rotational basis (support may be required outside normal working hours including nights, weekends, and holidays).
Lead or participate in teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.
Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to 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 these 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 experience in Biopharmaceutical operations/manufacturing environment
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, Clean Air generation and distribution, and CIP; and other Plant Utility equipment (chilled water, cooling towers, steam boilers, air compressors, etc.)
Experience with equipment and facility control systems operation, logic, and troubleshooting
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes such as change control, non‑conformances, corrective and preventive actions, and qualifications/validation
Strong leadership, technical writing, communication/presentation skills and the ability to work with minimum direction
Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team‑based environment
Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information
Ability to function within cross‑functional teams and embrace a team‑based environment
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
Understanding of the execution process 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
Great teammate prepared to work in and embrace a team‑based culture that relies on collaboration for effective decision‑making
Work schedule flexibility as required to support 24/7 operations, requiring occasional after‑hours engineering coverage.
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!
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Biotech / Pharmaceutical
Referrals increase your chances of interviewing at BioSpace by 2x
Get notified about new Process Engineer jobs in Holly Springs, NC.
North Carolina, United States
Durham, NC $63,000.00-$92,400.00 2 days ago
North Carolina, United States $80,000.00-$95,000.00 2 weeks ago
Raleigh, NC $80,000.00-$90,000.00 6 days ago
Holly Springs, NC $45.00-$60.00 2 days ago
North Carolina, United States 20 hours ago
Process Engineer III/ IV- Small Molecule/ Oligo/ Peptide
North Carolina, United States 4 months ago
Process Engineer V- Oral Solid Dosage (OSD Focus)
Raleigh, NC $110,000.00-$135,000.00 6 days ago
Sr. Process Engineer/Lead Process Engineer
Sr. Process Engineer (MSAT, GMP, Tech Transfer Role)
Senior Process Engineer - Capital Projects
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
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 feature best‑in‑class drug substance manufacturing technologies with embedded industry 4.0 capabilities, and will integrate sustainability innovations to reduce carbon and waste as part of Amgen’s plan to be a carbon‑neutral company by 2027.
What You Will Do
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 to the equipment or facility systems. Lead the development of a business case if required to support the completion of the project.
Develop equipment/instrument maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
Ensure systems are installed and operating safely and comply with pertinent environmental health/safety practices, rules and regulations.
Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.
Apply basic engineering principles and practices in support of 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 and/or supporting technical root cause analysis and implementation of corrective/preventive actions.
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
Own investigations of abnormal conditions through deviation and business 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 process equipment.
Work closely with multiple subject areas, including 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 an ongoing or project basis.
Provide technical support and issue resolution with 24x7 on‑call support of utility systems on a rotational basis (support may be required outside normal working hours including nights, weekends, and holidays).
Lead or participate in teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.
Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to 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 these 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 experience in Biopharmaceutical operations/manufacturing environment
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, Clean Air generation and distribution, and CIP; and other Plant Utility equipment (chilled water, cooling towers, steam boilers, air compressors, etc.)
Experience with equipment and facility control systems operation, logic, and troubleshooting
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes such as change control, non‑conformances, corrective and preventive actions, and qualifications/validation
Strong leadership, technical writing, communication/presentation skills and the ability to work with minimum direction
Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team‑based environment
Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information
Ability to function within cross‑functional teams and embrace a team‑based environment
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
Understanding of the execution process 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
Great teammate prepared to work in and embrace a team‑based culture that relies on collaboration for effective decision‑making
Work schedule flexibility as required to support 24/7 operations, requiring occasional after‑hours engineering coverage.
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!
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Biotech / Pharmaceutical
Referrals increase your chances of interviewing at BioSpace by 2x
Get notified about new Process Engineer jobs in Holly Springs, NC.
North Carolina, United States
Durham, NC $63,000.00-$92,400.00 2 days ago
North Carolina, United States $80,000.00-$95,000.00 2 weeks ago
Raleigh, NC $80,000.00-$90,000.00 6 days ago
Holly Springs, NC $45.00-$60.00 2 days ago
North Carolina, United States 20 hours ago
Process Engineer III/ IV- Small Molecule/ Oligo/ Peptide
North Carolina, United States 4 months ago
Process Engineer V- Oral Solid Dosage (OSD Focus)
Raleigh, NC $110,000.00-$135,000.00 6 days ago
Sr. Process Engineer/Lead Process Engineer
Sr. Process Engineer (MSAT, GMP, Tech Transfer Role)
Senior Process Engineer - Capital Projects
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr