Process Engineer – Upstream

Process Engineer – Upstream

Requirements

• High school diploma / GED and 8 years of Engineering/Maintenance experience OR
• Associate’s degree and 6 years of Engineering/Maintenance experience OR
• Bachelor’s degree and 5 years of Engineering/Maintenance experience OR
• Master’s degree
• 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 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 as well as other Plant Utility equipment needed to support these processes such as 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, etc.) 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.
• Proven 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 collaboration.
• 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.

Responsibilities

• 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 coordinating maintenance execution as vital to ensure systems are in proper working order.
• Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations.
• Ensure vital commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as vital.
• 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.
• Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• 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 sophisticated 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.
• Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
• Communicating 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 24×7 on-call support of Utility systems on a rotational based frequency (Support may be required outside of normal working hours including nights, weekends, and holidays).
• Lead or work with 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.

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 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 as well as other Plant Utility equipment needed to support these processes such as 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, etc.) 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.
• Proven 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 collaboration.
• 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.