Career CategoryEngineering
Job DescriptionSenior Engineer What you will doLet's do this. Let's change the world. In this vital role you will lead the design, optimization, and reliability of systems and equipment that power the delivery of high-quality, life-changing therapies.
Specific responsibilities include but are not limited to:- Serve as the system owner for assigned utilities, ensuring compliance with cGMP and regulatory standards.
- Monitor system performance daily and ensure operational reliability and environmental requirements are met.
- Own the lifecycle management of assigned systems, supporting preventive and predictive maintenance strategies.
- Ensure maintenance job plans and documentation are follows site standards and regulatory expectations.
- Evaluate systems and assess impact during outages or deviations, providing timely technical support and documentation.
- Participate in project meetings, offering technical expertise for design reviews and system modifications.
- Author and maintain user requirement specifications and system documentation.
- Identify and implement design or operational improvements to enhance efficiency and reliability.
- Incorporate industry best practices and regulatory updates into system design and operations.
- Lead root cause analysis for major deviations or failures, driving resolution with multi-functional teams.
- Analyze performance data to identify trends, anomalies, and opportunities for improvement.
- Translate technical insights into clear, actionable updates for non-technical collaborators.
- Collaborate with internal customers to understand needs and align engineering solutions accordingly.
- Share knowledge and best practices across teams and sites to promote consistency, innovation, and continuous improvement.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Senior Engineer professional we seek is an individual with these qualifications.
Basic Qualifications:Doctorate degree in Engineering
Or
Master's degree in Engineering and 2 years of Engineering and/or Mfg Support experience
Or
Bachelor's degree in Engineering and 4 years of Engineering and/or Mfg Support experience
Preferred Qualifications:- Working knowledge of pharmaceutical and biotechnology processes.
- Specialized expertise in industrial utilities, specifically in Reverse Osmosis, Water for Injection, and clean steam systems.
- Experience with utilities monitoring systems, including Building Management System (BMS), Process Control System (PCS), and PI data historian.
- Familiarity with Quality Management Systems (QMS), including validation, deviations, and CAPA management.
- Strong skills in problem solving, negotiation, persuasion, collaboration, project cost development, conflict resolution, leadership, team building, and schedule/resource planning.
- Effective verbal and written communication skills; proficiency in both Spanish and English.
- Flexibility to work extended shifts and/or weekends as required by business needs.
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
- 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 and an annual site shutdown
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
SponsorshipSponsorship for this role is not guaranteed.
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