Amgen

In this vital role Amgen’s Manufacturing Clinical Supply (MCS) Facilities and Engineering organization is seeking a highly motivated Senior Engineer to provide project engineering support to Drug Product, DP Assembly, and Synthetics areas.. Provide Commissioning & Qualification (C&Q) leadership to project teams to drive forward C&Q efforts for small projects (<$300K) such as equipment/utility/facility modifications to large capital projects (>$3M) that include facility construction and new equipment integration into clinical/commercial facilities.. 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, filler, isolator, cappers and lyophilization), 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.)

sr 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. Sr. Engineer Live What You Will Do Let’s do this. Let’s change the world. In this vital role Amgen’s Manufacturing Clinical Supply (MCS) Facilities and Engineering organization is seeking a highly motivated Senior Engineer to provide project engineering support to Drug Product, DP Assembly, and Synthetics areas. The candidate will play a key role in implementing new and modified equipment, facilities, and utilities and integrating new technologies to advance Amgen's clinical and commercial products' supply. Responsibilities: <ul><li>Provide technical leadership using engineering principles and drive forward projects varying from functional area projects focused on improving process equipment/utilities/facilities to large, complex capital projects to integrate new drug product manufacturing and device assembly and packaging technologies into clinical/commercial facilities. Leverage engineering expertise within the company and industry best practices, ensure compliance with pertinent environmental health and safety practices, and align with evolving regulatory expectations and internal quality standards to implement new equipment and/or equipment/utility/facility modifications.</li><li>Provide Commissioning & Qualification (C&Q) leadership to project teams to drive forward C&Q efforts for small projects (<$300K) such as equipment/utility/facility modifications to large capital projects (>$3M) that include facility construction and new equipment integration into clinical/commercial facilities. This includes ensuring effective communication flow between cross-functional teams (e.g. F&E, Manufacturing, Quality, Project controls, project management, EHSS) and functional management, leading the selection of contractors for C&Q execution, managing their training and performance, C&Q deliverables and schedule to meet project timelines, and ensuring compliance with Amgen safety, C&Q and Quality standards.</li><li>Manage the portfolio of improvement/innovation projects within the F&E drug product engineering group using strategic approaches and resource prioritization.</li><li>Be knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance and support regulatory inspections and audits.</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: Doctorate degree Or Master’s degree and 2 years of Engineering and/or Operations experience Or Bachelor’s degree and 4 years of Engineering and/or Operations experience Or Associate’s degree and 8 years of Engineering and/or Operations experience Or High school diploma / GED and 10 years of Engineering and/or Operations experience Preferred Qualifications: <ul><li>Master’s degree in Chemical or Mechanical Engineering</li><li>6+ years of relevant work experience with 3+ 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, filler, isolator, cappers and lyophilization), 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>Team player 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></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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