Clean Utilities Sr Engineer

About the role

The Utilities Systems Owner plays a critical role in ensuring the smooth operation of clean and plant utility systems and equipment supporting drug substance production at the site. They provide engineering support for design, construction, startup, commissioning, and qualification of new or modified systems. Additionally, they are responsible for maintaining systems to ensure they are safe and compliant with environmental health/safety practices and regulations.

Responsibilities

• Provide system ownership for Clean and Plant Utility systems and equipment supporting operations at the site.
• Support the development of equipment maintenance programs and ensure the availability of spare parts.
• Lead the development of business cases for engineering-based improvements or upgrades in small to medium scope and complexity.
• Develop and implement condition based and predictive maintenance practices.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Provide troubleshooting support to reduce production downtime, leading and supporting technical root cause analysis and implementation of corrective/preventive action.
• Advocate for the use of advanced data analytics in maintenance practices.
• Own investigations of abnormal conditions through Deviations and business processes.

Requirements

• High school diploma/GED and 10 years of Engineering/Maintenance experience OR Associates degree and 8 years of Engineering/Maintenance experience OR Bachelors degree and 4 years of Engineering/Maintenance experience OR Masters degree and 2 years of Engineering/Maintenance experience OR Doctorate degree
• Bachelor's degree in Chemical, Mechanical, or Electrical Engineering preferred
• 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 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.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.).
• 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 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.
• 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.

Qualifications

• Basic qualifications: High school diploma/GED and 10 years of Engineering/Maintenance experience OR Associates degree and 8 years of Engineering/Maintenance experience OR Bachelors degree and 4 years of Engineering/Maintenance experience OR Masters degree and 2 years of Engineering/Maintenance experience OR Doctorate degree

Skills

• Basic engineering principles and practices
• Data-driven problem solving techniques
• Engineering principles applied to system modifications and process introductions
• Capital project execution in a GMP Biopharmaceutical Production facility
• Safety requirements in a GMP Biopharmaceutical Production facility
• Leadership, technical writing, and communication/presentation skills
• Work schedule flexibility and ability for international travel

Benefits

Amgen offers 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. Additionally, there is a discretionary annual bonus program or for field sales representatives, a sales-based incentive plan. Stock-based long-term incentives are also available. Other benefits include award-winning time-off plans and flexible work models where possible.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Schedule

Flexible work models where possible.