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Downstream Process Engineer - Holly Springs, NC
VetJobs, Holly Springs, North Carolina, United States, 27540
Downstream Process Engineer - Holly Springs, NC
Join the Downstream Process Engineer role at Amgen in Holly Springs, NC. This on-site position reports to the Senior Manager of the Process Engineering group and provides daily engineering support at the Amgen North Carolina site. 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 lead engineering-based improvements or upgrades; develop a business case as needed. Develop equipment/instrument maintenance programs; ensure spare parts availability and coordinate maintenance. Ensure systems comply with safety and environmental regulations; complete commissioning and qualification aligned with GMP requirements. Apply basic engineering principles to operation, maintenance, and troubleshooting; monitor systems and implement risk reductions. Provide troubleshooting support to reduce downtime; lead or support root cause analysis and corrective/preventive actions. Support new product/technology introductions; perform engineering assessments and support engineering runs. Advance condition-based and predictive maintenance with data analytics where applicable. Own investigations of abnormal conditions, develop operational issue analyses and present results. Provide technical support to commercial and clinical manufacturing; collaborate with cross-functional teams to implement improvements. Participate in 24x7 on-call support for utility systems as needed; after-hours coverage may be required. Lead or participate in design and selection of new systems, instruments, and calibration capabilities. Evaluate suppliers and technologies for cost savings and capabilities. Qualifications
Basic Qualifications High School Diploma / GED with 8 years of Engineering experience OR Associate’s Degree with 6 years of Engineering experience OR Bachelor’s Degree with 2 years of Engineering experience OR Master’s Degree Preferred Qualifications Downstream process equipment experience; degree in Chemical or Mechanical engineering; 6+ years of relevant experience in Biopharmaceutical operations/manufacturing; GMP knowledge of plant utilities and equipment. Experience with equipment and facility control systems operation, logic, and troubleshooting. Experience in regulated environments (cGMP, OSHA, EPA) and quality systems (change control, non-conformances, CAPA, validation). Strong leadership, communication, and teamwork skills; ability to work with minimal direction. Ability to apply analytical skills to complex problems; cross-functional collaboration. Understanding of capital project execution in GMP Biopharmaceutical facilities. Flexible schedule to support 24/7 operations. Details
Location: Holly Springs, North Carolina Employer: Amgen Salary Range: 93,344.00 USD - 107,268.00 USD
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Join the Downstream Process Engineer role at Amgen in Holly Springs, NC. This on-site position reports to the Senior Manager of the Process Engineering group and provides daily engineering support at the Amgen North Carolina site. 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 lead engineering-based improvements or upgrades; develop a business case as needed. Develop equipment/instrument maintenance programs; ensure spare parts availability and coordinate maintenance. Ensure systems comply with safety and environmental regulations; complete commissioning and qualification aligned with GMP requirements. Apply basic engineering principles to operation, maintenance, and troubleshooting; monitor systems and implement risk reductions. Provide troubleshooting support to reduce downtime; lead or support root cause analysis and corrective/preventive actions. Support new product/technology introductions; perform engineering assessments and support engineering runs. Advance condition-based and predictive maintenance with data analytics where applicable. Own investigations of abnormal conditions, develop operational issue analyses and present results. Provide technical support to commercial and clinical manufacturing; collaborate with cross-functional teams to implement improvements. Participate in 24x7 on-call support for utility systems as needed; after-hours coverage may be required. Lead or participate in design and selection of new systems, instruments, and calibration capabilities. Evaluate suppliers and technologies for cost savings and capabilities. Qualifications
Basic Qualifications High School Diploma / GED with 8 years of Engineering experience OR Associate’s Degree with 6 years of Engineering experience OR Bachelor’s Degree with 2 years of Engineering experience OR Master’s Degree Preferred Qualifications Downstream process equipment experience; degree in Chemical or Mechanical engineering; 6+ years of relevant experience in Biopharmaceutical operations/manufacturing; GMP knowledge of plant utilities and equipment. Experience with equipment and facility control systems operation, logic, and troubleshooting. Experience in regulated environments (cGMP, OSHA, EPA) and quality systems (change control, non-conformances, CAPA, validation). Strong leadership, communication, and teamwork skills; ability to work with minimal direction. Ability to apply analytical skills to complex problems; cross-functional collaboration. Understanding of capital project execution in GMP Biopharmaceutical facilities. Flexible schedule to support 24/7 operations. Details
Location: Holly Springs, North Carolina Employer: Amgen Salary Range: 93,344.00 USD - 107,268.00 USD
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