Process Equipment Engineer at Amgen

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Equipment Engineer

Lets do this! Lets change the world! In this vital role you will support manufacturing processes in Thousand Oaks Pilot Plant. Responsibilities include providing operational support, troubleshooting, and optimization for assigned equipment; advising and applying engineering principles to the design and implementation of new equipment (Stainless and Single Use Systems).

• Support system reliability and operational optimization efforts. Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies. Lead and execute improvement efforts (including identifying cycle reduction time opportunities, efficiency gains, and yield improvement opportunities)
• Lead or support technical root cause analysis, incident investigations, and solving on equipment. Previous training and experience is preferred.
• Analyze problems, develop and propose engineering solutions in a scientific manner using data techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)
• Support new product introductions or new technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs
• Develop, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity
• Provide ad hoc technical support for equipment troubleshooting.
• This role involves the application of process engineering principles in the design, specification, construction, startup, and validation of process equipment and systems for capital projects of moderate scope and complexity. Candidate should have previous exposure to project engineering processes from initial conceptualization through project turnover to operations.
• Ensures the logical, detailed translation of design requirements and constraints into process equipment/system solutions. Assists with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements
• Desired skills include demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices; ability to apply standard engineering principles and practices to work assignments; and ability to employ basics techniques within area of engineering expertise
• Communicating proactively with supervisor and support staff, highlighting issues and proposing solutions
• Support a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations.

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

Basic Qualifications:

Masters degree

Bachelors degree and 2 years of Engineering experience

Associates degree and 6 years of Engineering experience

High school diploma / GED and 8 years of Engineering experience

Preferred Qualifications:

• Bachelors degree in Chemical Engineering, Mechanical Engineering, or Bioengineering preferred
• 4+ years of meaningful work experience with 2+ year experience in operations/manufacturing environment
• Direct experience with regulated environments (e.g. FDA, cGMP, OSHA, EPA, etc.) is preferred.
• Subject Matter Expert and hands-on experience with complex manufacturing process equipment including sophisticated troubleshooting, reliability and performance improvements, and design optimization.
• Direct experience in equipment engineering and problem solving for centrifuges, chromatography columns and systems, and/or ultrafiltration/defiltration systems.
• Have a foundational knowledge of Maximo for managing equipment maintenance and asset lifecycle.
• Solid understanding and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in corrective and preventative actions, and commissioning practices.
• Experience supporting design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation is preferred.
• Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
• Individual must be a teammate prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
• Experience in having continuous improvement mindset in day to day activities
• Ability to apply sophisticated and diverse engineering principles to the design and implementation of major system modifications, introduction of new processes, and capital projects. Develop technical solutions to sophisticated problems requiring the regular use of resourcefulness and creativity.
• Developed contingency plan for potential obstacles or setbacks
• Proficient in leveraging data and analytics to evaluate safety and quality impacts and to cultivate a safety culture
• Demonstrated interest in continuous learning opportunities around new tools, techniques, and configurations to enhance their analytical abilities.
• Strong leadership, technical writing, and communication/presentation skills are required.
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage and on call support.

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, well 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, including remote and hybrid work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.

Amgen anticipates accepting applications until 11/13/2024; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

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.