Senior Engineer

Amgen SA; Thousand Oaks, Northern (CA, KY); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Amgen is seeking a Senior Engineer to provide engineering support for Drug Substance facilities. You will lead improvements, coordinate maintenance, and ensure systems meet safety and regulatory standards during commissioning and validation.

Ideal candidates will bring advanced engineering degrees and extensive GMP biopharma experience, with leadership, data-driven problem-solving, and strong communication skills to drive continuous improvement and support 24/7 operations.

Qualifications

• Doctorate in engineering or related field required.
• Advanced degree with 2+ years engineering experience or equivalent.
• Bachelor’s with 4+ years engineering experience or higher.
• Extensive exposure to GMP biopharma environments preferred.

Responsibilities

• Implement engineering improvements and equipment upgrades with business-case development.
• Coordinate maintenance to ensure systems are in good order.
• Ensure commissioning/qualification and regulatory interface as needed.
• Develop metrics to measure maintenance effectiveness and performance.
• Troubleshoot to reduce downtime and lead root-cause analyses.
• Support new product introductions and capital projects.

Skills

Leadership

Technical writing

Communication

Multi-tasking

Education

Doctorate degree

Master’s degree + 2 yrs experience

Bachelor’s degree + 4 yrs experience

Associate’s degree + 8 yrs experience

High school diploma / GED + 10 yrs experience

Tools

GMP equipment

Autoclaves

CIP systems

Clean steam

Job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Engineer

What you will do

Let’s do this. Let’s change the world. In this vital role you will work with the Sr. Engineering Manager and will provide engineering support for the Drug Substance facilities.

• Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order
• Ensure necessary commissioning and qualification of systems is completed and interact with inspectors
• Develop metrics-based performance focused on the maintenance systems effectiveness and operating level performance.
• 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, identifying spare parts, job plan development and supporting engineering runs.
• Ensure systems are installed and operating safety and align with pertinent environmental health/safety practice, rules and regulations
• Responsible for determining appropriate CAPAs, action plan development, QMTS data entry, owns the record, initiate child CAPA’s and CAPA EVs, timely closure and responses, provision of technical data and reports.
• Use tools and techniques of continuous improvement wherever possible. Establish equipment monitoring parameters and control limits. Routinely provide updates on metrics. Provide 2nd tier trouble shooting to support ops and maintenance groups as follow on from tier 1 initial problem solving. Change over reduction projects. Failure trending
• Up to 10% domestic travel

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications

• Doctorate degree
• OR
• Master’s degree and 2 years of engineeringexperience
• OR
• Bachelor’s degree and 4 years of engineering experience
• OR
• Associate’s degree and 8 years of engineering experience
• OR
• High school diploma / GED and 10 years of engineering experience

Preferred Qualifications

• Bachelor’s degree in Biotechnology, Industrial, Chemical or Mechanical Engineering
• 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
• 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
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• 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, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
• Team player 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 to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

In 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.