Process Equipment Engineer

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

• POSITION TITLE]
• Live
• What you will do
• Job Description

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).

• Responsibilities :
• 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.
• What we expect of you

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.
• 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.
• Thrive
• What you can expect of us

As 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.

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.

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 :

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible
• Apply now
• for a career that defies imagination

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

• careers.amgen.com
• Application deadline
• External / Internal postings :

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.

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.

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.