Manufacturing Information

1 week ago


Dublin, Dublin City, Ireland Amgen Sa Full time

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
L
ead 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 d
esign and deliver
Proof-of-Concept
s
(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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