Senior Process Engineer

Senior Process 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. 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. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest disposable technologies with traditional stainless‑steel equipment to allow for maximum flexibility in operations. The facility features best‑in‑class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and sustainability innovations to reduce carbon and waste as part of Amgen's plan to be a carbon‑neutral company. What You Will Do Let’s do this. Let’s change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise and system ownership to support process operations, focusing on Downstream Process engineering. Responsibilities include: Provide system ownership for biopharmaceutical process equipment and identify, support, or lead engineering‑based improvements or upgrades to equipment or facility systems, including development of business cases, design requirements, and translation of requirements into process equipment/system design, specifications, and support for construction, startup, and validation. Effectively collaborate with key customers and support groups (e.g., Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations. Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to keep systems in proper working order. Ensure systems are installed and operate safely and remain in sync with environmental health and safety practices, rules, and regulations. Ensure commissioning and qualification of systems are completed in alignment with GMP requirements and interact with regulatory inspectors. Provide guidance to identify performance risks and implement risk‑reduction strategies. Provide problem‑solving support to reduce production downtime, including leading technical root‑cause analysis and implementing corrective/preventive action. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Provide rotational on‑call support and ensure 24/7 day‑to‑day reliability of upstream and downstream systems for plant operations. Provide technical mastery and problem‑solving leadership to proactively reduce production downtime, leading technical root‑cause analysis and implementation of corrective/preventive actions for families of systems. Ensure plant readiness and compliance for internal audits, external agency audits, and partner audits for the process equipment. Lead new product/technology introductions through engineering assessments, performance risk assessments, gap identification, remediation ownership, equipment modifications, and engineering runs. What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications. Basic Qualifications Doctorate degree Master’s degree and 2 years of engineering experience Bachelor’s degree and 4 years of engineering experience Associate’s degree and 8 years of engineering experience High school diploma / GED and 10 years of engineering experience Preferred Qualifications Bachelor’s degree in Chemical or Mechanical Engineering 6+ years of relevant work experience, including 5+ years in a biopharmaceutical operations/manufacturing environment with a focus on downstream unit operations Direct knowledge of design and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration, and related support equipment (e.g., autoclaves, CIP systems, washers, clean steam, water for injection) Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data‑driven techniques and analyses (e.g., data analytics, root cause analysis, SPC, Six Sigma, predictive maintenance) Experience working in a regulated environment (e.g., cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes such as change control, non‑conformances, corrective and preventive actions, and qualifications/validation Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and oversight of capital projects Understanding of capital projects in a GMP biopharmaceutical production facility, including procurement, construction, startup, and validation Understanding of safety requirements in a GMP biopharmaceutical production facility Independent, ambitious, organized, able to multi‑task in project environments, and skilled in communication, facilitation, and teamwork Collaborative teammate prepared to work in and embrace a team‑based environment that relies on communication for effective decision‑making Strong leadership, technical writing, and presentation skills Availability for 24/7 operations with occasional after‑hours engineering coverage Ability for domestic/international travel (~10%) What You Can Expect Of Us Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward 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. Discretionary annual bonus program and sales‑based incentive plans for field sales representatives 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 Objects in your future are closer than they appear. Join us. 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. #J-18808-Ljbffr