Manufacturing Information & Technology Systems Engineer
Manufacturing Information & Technology Systems Engineer
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Job Description
Career Category
Information SystemsJob Description
Amgen is the worlds 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 20000 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 PASX 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
Masters degree and 4 years of manufacturing or information systems experience OR
Bachelors degree and 8 years of manufacturing or information systems experience
Preferred Qualifications
Bachelors or Masters 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. PASX) 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 peoples lives. A biotechnology pioneer since 1980 Amgen has grown to be one of the worlds leading independent biotechnology companies has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Employment Type
Full-Time
