Principal Manufacturing Systems Engineer

Amgen • Juncos, PR

16d

About The Position

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 lay 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 System Engineer What you will do In this vital role, you will be accountable for shaping and aligning the site manufacturing information ecosystem for our Drug Product Manufacturing organization in Juncos, Puerto Rico with evolving business needs and Amgen IS technical roadmaps. You will have the opportunity to apply leading and emerging digital technologies to systems that enable the successful development, design, manufacturing, distribution and commercialization of Amgen products. In addition, you will lead complex IS initiatives applying strong analytical problem-solving, management, and lifecycle governance expertise. This role will focus on digital manufacturing platforms including MES, data historian, advanced analytics, AI-enabled solutions, and enterprise system integrations aligned with Industry 4.0 / Smart Manufacturing principles.

Requirements

• Doctorate degree in Engineering & 2 years of information system and/or engineering industry experience OR Master’s degree in Engineering & 4 years of information system and/or engineering industry experience OR Bachelor’s degree in Engineering & 6 years of information system and/or engineering industry experience

Nice To Haves

• Excellent communication and interpersonal skills, with the ability to build strong relationships with stakeholders at all levels of the organization and across Amgen’s international network.
• 8+ years’ experience in a manufacturing environment with 5+ years in the Pharmaceutical, Medical Device and/or Biotechnology industries.
• 5+ years’ experience with manufacturing and enterprise platforms such as: Enterprise integration platforms, Rockwell Automation platform, MES (e.g., Körber or equivalent)Data Historian platforms (e.g., OSI PI),Warehouse and/or Laboratory Systems.
• Strong analytical skills and understanding of digital manufacturing data flows across drug product operations.
• Experience managing multiple projects simultaneously and delivering results in a highly fluid, interactive matrixed environment with the ability to lead various initiatives and effectively prioritize in a dynamic atmosphere.
• Experience with data architecture, system integration methods (e.g., SQL, APIs, web services, messaging, data mapping).
• Experience with cloud and hybrid IS infrastructure environments (Storage, Virtualization, Networking, Active Directory, etc.).
• Ability to translate digital strategy into pragmatic, executable roadmaps aligned with enterprise standards.
• Strong knowledge of GAMP, 21 CFR Part 11, and regulatory requirements for computerized systems.
• Experience with system validation, lifecycle management, and change control.
• Hands-on experience supporting, optimizing, and enhancing computerized manufacturing systems.
• Experience working with agile methodologies (e.g., Scrum, DevOps)
• Fluent English proficiency—both written and verbal.
• Availability to travel as per business needs.

Responsibilities

• Lead the execution of a diverse portfolio of IS and digital initiatives with effective portfolio planning, resource management, risk management, and financial oversight.
• Drive alignment between site systems and enterprise IS strategies and standards.
• Monitor industry and technology trends in digital manufacturing, data analytics, AI, and smart factory capabilities to inform site strategy.
• Perform cross-system analysis, feasibility studies, project scoping, prioritization of deliverables, and recommend optimal digital solutions.
• Manage multiple concurrent initiatives while ensuring alignment with compliance, cybersecurity, and data governance requirements.
• Build and maintain effective working relationships with IS service owners, business stakeholders, enterprise partners, and vendors.
• Elicit and translate business requirements into functional and technical design documentation.
• Ensure robust lifecycle management, validation, and change control for manufacturing information systems.

Benefits

• 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 that may include:
• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal