Amgen

Ensure systems are installed and operating safety and follow pertinent environmental health/safety practice, rules and regulations.. 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 continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, device assembly, cell culture reactors, chromatography, filtration 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.). Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation

engineer

HOW MIGHT YOU DEFY IMAGINATION? You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Engineer Live What You Will Do Let’s do this. Let’s change the world. In this vital role The Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical Supply organization at Amgen. The group’s mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report into the Principal Engineer supporting drug product supply at Amgen Thousand Oaks site. Responsibilities: <ul><li>Provide system ownership for Biopharmaceutical process equipment. 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.</li><li>Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.</li><li>Ensure commissioning and qualification of systems is completed and interact with inspectors as necessary.</li><li>Monitor systems to identify performance risks and implement risk reduction strategies.</li><li>Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.</li><li>Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.</li><li>Ensure systems are installed and operating safety and follow pertinent environmental health/safety practice, rules and regulations.</li><li>Up to 10% domestic/international travel </li></ul>Win 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 an individual with these qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of Engineering or Process Development experience Or Associate’s degree and 6 years of Engineering or Process Development experience Or High school diploma / GED and 8 years of Engineering or Process Development experience Preferred Qualifications: <ul><li>Bachelor’s degree in Chemical or Mechanical Engineering</li><li>3+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment</li><li>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</li><li>Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, device assembly, cell culture reactors, chromatography, filtration 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.</li><li>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.)</li><li>Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects</li><li>Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation</li><li>Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.</li><li>Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration</li><li>Teammate prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making</li><li>Strong leadership, technical writing, and communication/presentation skills</li><li>Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage </li></ul>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: <ul><li>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.</li><li>A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan</li><li>Stock-based long-term incentives</li><li>Award-winning time-off plans and bi-annual company-wide shutdowns</li><li>Flexible work models, including remote work arrangements, where possible </li></ul>Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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.

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