Clean Utilities Sr Engineer

Clean Utilities Sr. Engineer What You Will Do Provide system ownership for Clean and Plant 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 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 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 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 advanced data analytics where applicable. Own investigations of abnormal conditions through Deviation and business processes. Basic Qualifications High school diploma / GED and 10 years of Engineering/Maintenance experience Associates degree and 8 years of Engineering/Maintenance experience Bachelor's degree and 4 years of Engineering/Maintenance experience Master's degree and 2 years of Engineering/Maintenance experience Doctorate degree Preferred Qualifications Bachelor's degree in Chemical, Mechanical, or Electrical Engineering 4+ years of relevant work experience with 2+ years 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, and Clean Air generation and distribution; and 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 Ability to analyze problems and develop engineering solutions with data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis, Statistical Process Control, Six Sigma, Predictive Maintenance) 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 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 Strong leadership, technical writing, and communication/presentation skills Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage Ability for domestic/international travel Benefits A comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible 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. #J-18808-Ljbffr BioSpace