Principal Manufacturing Systems Engineer
Initial Therapeutics, Inc. - West Greenwich, RI
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Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Principal Manufacturing Systems Engineer What you will do Let's do this! Let's change the world! In this vital role, you will provide automation technical leadership to a group of Automation Engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. In this vital role as a member of the Facilities & Engineering (F&E) Automation team, you will work hand in hand with project teams and site operations teams to deliver robust automation systems to operate multiple manufacturing facilities. This includes complex and challenging system automation initiatives that require a detailed understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management, and Operational Excellence. Responsibilities: Develop and maintain process control automation solutions applying DeltaV Distributed Control System (DCS), Human Machine Interfaces (HMI), Building Management Systems (BMS), and Supervisory Control and Data Acquisition systems (SCADA) spanning the entire S88 model. Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions. Collaborate with business partners to understand how automation can improve workflow and productivity. Synthesize requirements from clients, customers, or end-users to develop the best automation solutions. Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards. Build the business processes to support project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units. Build a robust talent pipeline with diverse capabilities. Partner with HR to recruit, coach, develop, motivate, and retain staff. Ensure an ongoing organizational structure capable of adapting to evolving business needs. Establish technical training, leadership training, and cross-training plans to continually develop staff and build breadth and depth in the organization. Partner with staff to establish robust long-term development plans aligned with their aspirations and build robust succession plans through awareness of site, network, and external talent. Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility. Lead/support technical root cause analysis, incident investigations, and solving problems on process control issues related to plant operations. Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable. Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost-effectively. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a self-directed teammate ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making. Basic Qualifications: High school diploma / GED and 12 years of Manufacturing Automation Engineering experience OR Associate degree and 10 years of Manufacturing Automation Engineering experience OR Bachelor's degree and 6 years of Manufacturing Automation Engineering experience OR Master's degree and 4 years of Manufacturing Automation Engineering experience OR Doctorate degree and 2 years of Manufacturing Automation Engineering experience. Preferred Qualifications: Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech Engineering. Direct knowledge of Automation design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems. Extensive understanding and background in programming, design, installation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies. Experience with Emerson Delta-V DCS system and Process Control Network design. Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment. Experience in Capital Project Lifecycle Management. Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment. Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity. Strong leadership, technical writing, and communication/presentation skills. What you can expect of us 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, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. is posted. Actual salary will vary based on several factors including 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. A comprehensive employee benefits package. A discretionary annual bonus program. Stock-based long-term incentives. Award-winning time-off plans. Flexible work models, including remote and hybrid 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 In any materials you submit, you may redact or remove age-identifying information. You will not be penalized for redacting or removing this information. Application deadline 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. 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. 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. #J-18808-Ljbffr
Created: 2025-02-13