BioSpace
Engineer Systems Owner - Utilities Engineer
BioSpace, Holly Springs, North Carolina, United States, 27540
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 Utility 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 coordinating 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 practice, 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 or supporting root cause analysis and corrective/preventive action.
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 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.
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 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 hours including nights, weekends, and holidays).
Lead or contribute to 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 for 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
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, chillers, 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 preventative 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 complex problems using multiple information sources.
Ability to work 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 in a GMP Biopharmaceutical Production facility.
Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork.
Team-oriented and collaborative approach to decision-making
Willingness to support 24/7 operations with occasional after-hours engineering coverage
What You Can Expect Of Us We provide opportunities for professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we will support your journey.
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.
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 provide reasonable accommodation to participate in the job application or interview process; please contact us to request accommodation.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology
Industries
Biopharmaceutical/Manufacturing
#J-18808-Ljbffr
What You Will Do
Provide system ownership for Utility 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 coordinating 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 practice, 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 or supporting root cause analysis and corrective/preventive action.
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 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.
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 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 hours including nights, weekends, and holidays).
Lead or contribute to 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 for 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
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, chillers, 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 preventative 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 complex problems using multiple information sources.
Ability to work 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 in a GMP Biopharmaceutical Production facility.
Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork.
Team-oriented and collaborative approach to decision-making
Willingness to support 24/7 operations with occasional after-hours engineering coverage
What You Can Expect Of Us We provide opportunities for professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we will support your journey.
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.
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 provide reasonable accommodation to participate in the job application or interview process; please contact us to request accommodation.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology
Industries
Biopharmaceutical/Manufacturing
#J-18808-Ljbffr