Manufacturing Information

Amgen is the world's leading biopharmaceutical company with a versatile portfolio of products. Our science-based approach has led to the discovery of novel therapies in the areas of cardiovascular disease, oncology, bone health, neuroscience, nephrology, and inflammation. Our patient-centered culture fuels our commitment to delivering innovative medicine systems and exceptional experiences. You will be joining a team of over 20,000 colleagues driven by one mission: to serve every patient, every time.

Are you looking for a meaningful opportunity to apply the latest emerging technologies to systems that enable the development, design, manufacturing, and distribution of Amgen products? We are seeking a creative, innovative, and strategic technology professional to architect and lead the deployment of Manufacturing Information & Technology Systems, focusing on system integration, automation, data collection, at our Dublin manufacturing facility, in alignment with Industry 4.0 / Smart Manufacturing principles.

Live – What You Will Do

As a key member of the Technology and Innovation team, you will drive the development and support of technologies used in our manufacturing operations. This role will collaborate with business owners, vendors, and delivery teams to implement cutting-edge technologies that directly impact how we get products to every patient.

Responsibilities

- Lead the design and integration of the Manufacturing Information & Technology ecosystem, ensuring alignment with business goals and IT strategy.

- Champion Werum PAS|X MES (Level 2 Integration) with automation systems to enable seamless data flow and real-time operational insight.

- Configure and maintain OPC (OLE for Process Control) connectivity and troubleshoot integration issues between systems.

- Manage and support OSI PI Historian implementation for process data collection, trending, and reporting.

- Business partner with Direct Manufacturing, Automation, and Manufacturing Support teams to identify needs and co-develop digital solutions.

- Own the technology roadmap for manufacturing systems, ensuring long-term scalability, security, and compliance.

- Collaborate with service owners and platform teams to maintain operational systems and ensure compliance with cybersecurity controls.

- Partner with business units to develop use cases, user stories, and functional requirements and design and deliver Proof-of-Concepts (POC)

- Support regulatory inspections and internal audits; ensure audit-readiness through documentation, change management, and validation support.

- Lead or support deviation investigations, reactive support, and root cause analysis (RCA) using structured methodologies.

- Facilitate communication and presentations across cross-functional teams, from technical peers to senior leadership.

- Stay updated with industry trends, fostering knowledge-sharing and external networking to bring innovation into practice.

- Ensure adherence to 21 CFR Part 11, CSV, SDLC, and other relevant regulatory and quality frameworks.

Win – What We Expect of You

Basic Qualifications

- Master's degree and 4 years of manufacturing or information systems experience, OR

- Bachelor's degree and 8 years of manufacturing or information systems experience

Preferred Qualifications

- Bachelor's or Master's Degree in Computer Science, Engineering, or Information Systems

- 8+ years of experience in a manufacturing environment, with 5+ years in pharmaceutical or biotechnology industries

- Proficiency with Manufacturing Execution Systems (e.g., PAS|X) and data historians (e.g., OSI PI)

- Experience with OPC setup, SQL, web services, messaging, and data mapping for system integration

- Familiarity with GxP, change control, validation documentation, and audit processes

- Strong experience with process automation platforms

- Excellent communication and presentation skills

- Strong interpersonal skills with a proven ability to collaborate in team-based, cross-functional environments

- Ability to lead multiple initiatives and prioritize effectively in fast-paced environments

- Energetic, self-driven, and passionate about applying technology to improve manufacturing outcomes

Thrive – What You Can Expect From Us

We understand that thriving means different things to different people. At Amgen, we offer:

- Vast opportunities for learning, development, and internal mobility

- A comprehensive Total Rewards Plan including healthcare, retirement, and career benefits

- Flexible work arrangements to support work-life balance

- A collaborative and inclusive work culture with a powerful mission to serve patients

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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