2 Data Processing jobs in Ireland
Manufacturing Information & Technology Systems Engineer
Amgen
Posted 8 days ago
Job Viewed
Job Description
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-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.
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-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.
This advertiser has chosen not to accept applicants from your region.
0
Pharmacovigilance Data Analysis Manager
Dublin, Leinster
Grifols Shared Services North America, Inc
Posted 15 days ago
Job Viewed
Job Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.**
Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a _Pharmacovigilance Data Analysis Manager_ like you.
Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement initiatives. Act as a key liaison with IT system administrators to validate and test system changes, ensuring compliance and alignment with business needs.
**What your responsibilities will be**
+ Lead and coordinate safety data analysis for aggregate reports preparation, signal management and ad hoc requests.
+ Support drug safety systems through business administration tasks, including database configuration updates, submission rules management and testing with regulatory authorities.
+ Serve as a subject matter expert in delivering and evaluating cost-effective, sustainable solutions that meet business requirements.
+ Manage documentation related to PV systems and applications, including SOPs, WPs, user requirements, functional/ technical specifications and process flow diagrams.
+ Drive change management initiatives to ensure smooth adoption of new processes and support the integration of new applications within the PV team.
+ Collect, prioritize and plan system improvements based on user feedback, while ensuring compliance with regulatory requirements.
+ Act as the primary PV contact for IT-related PV projects.
+ Drive Innovation through AI in Pharmacovigilance: Stay at the forefront of artificial intelligence advancements to identify and evaluate innovative technologies and processes that can enhance pharmacovigilance operations. This includes proactively assessing AI-driven tools and methodologies to improve signal detection, case processing, data analysis and regulatory compliance. Collaborate cross-functionally to pilot and implement solutions that increase efficiency, accuracy, and strategic value in safety monitoring.
**Who you are**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ You have a bachelor's degree in Health Sciences (pharmacy, nursing, medicine, veterinary, etc) or Bioscience (biochemistry, biotechnology, biology, etc). Additional training and/or experience in bioinformatics/biostatistics or data analysis tools (such as R or Power BI).
+ You have at least 4 years of pharmacovigilance experience including management of pharmacovigilance data bases.
+ You have proven knowledge of Good Pharmacovigilance Practices; existing legislation, regulations, guidelines, medical coding and safety-data administration.
+ You are proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).
+ Familiarity with reporting tools such as Business Objects is strongly preferred.
+ You have knowledge of E2b (R2) and E2b (R3) and to be familiarity with medical terminology, MedDRA, WhoDrug are a plus.
+ You speak fluent Spanish and English.
+ You are proven self-starter with strong work ethic and the ability to exercise good judgment.
+ You must be proactive, results oriented and have strong attention to detail.
+ Strong organizational, analytical and problem-solving skills with the ability to make structured decisions on a routine basis.
+ Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
+ You possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
+ Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines.
**What we offer**
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!
We look forward to receiving your application!
**We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.**
Grifols is an equal opportunity employer.
**Flexible schedule:** Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).
**Benefits package**
**Contract of Employment:** Permanent position
**Flexibility for U Program:** Hybrid
**Location:** Sant Cugat del Vallès (preferably) / Other locations as Los Angeles, Clayton or Dublin will be considered
more about Grifols
**Req ID:** 531655
**Type:** Indefinido tiempo completo
**Job Category:** I + D
**We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.**
Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a _Pharmacovigilance Data Analysis Manager_ like you.
Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement initiatives. Act as a key liaison with IT system administrators to validate and test system changes, ensuring compliance and alignment with business needs.
**What your responsibilities will be**
+ Lead and coordinate safety data analysis for aggregate reports preparation, signal management and ad hoc requests.
+ Support drug safety systems through business administration tasks, including database configuration updates, submission rules management and testing with regulatory authorities.
+ Serve as a subject matter expert in delivering and evaluating cost-effective, sustainable solutions that meet business requirements.
+ Manage documentation related to PV systems and applications, including SOPs, WPs, user requirements, functional/ technical specifications and process flow diagrams.
+ Drive change management initiatives to ensure smooth adoption of new processes and support the integration of new applications within the PV team.
+ Collect, prioritize and plan system improvements based on user feedback, while ensuring compliance with regulatory requirements.
+ Act as the primary PV contact for IT-related PV projects.
+ Drive Innovation through AI in Pharmacovigilance: Stay at the forefront of artificial intelligence advancements to identify and evaluate innovative technologies and processes that can enhance pharmacovigilance operations. This includes proactively assessing AI-driven tools and methodologies to improve signal detection, case processing, data analysis and regulatory compliance. Collaborate cross-functionally to pilot and implement solutions that increase efficiency, accuracy, and strategic value in safety monitoring.
**Who you are**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ You have a bachelor's degree in Health Sciences (pharmacy, nursing, medicine, veterinary, etc) or Bioscience (biochemistry, biotechnology, biology, etc). Additional training and/or experience in bioinformatics/biostatistics or data analysis tools (such as R or Power BI).
+ You have at least 4 years of pharmacovigilance experience including management of pharmacovigilance data bases.
+ You have proven knowledge of Good Pharmacovigilance Practices; existing legislation, regulations, guidelines, medical coding and safety-data administration.
+ You are proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).
+ Familiarity with reporting tools such as Business Objects is strongly preferred.
+ You have knowledge of E2b (R2) and E2b (R3) and to be familiarity with medical terminology, MedDRA, WhoDrug are a plus.
+ You speak fluent Spanish and English.
+ You are proven self-starter with strong work ethic and the ability to exercise good judgment.
+ You must be proactive, results oriented and have strong attention to detail.
+ Strong organizational, analytical and problem-solving skills with the ability to make structured decisions on a routine basis.
+ Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
+ You possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
+ Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines.
**What we offer**
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!
We look forward to receiving your application!
**We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.**
Grifols is an equal opportunity employer.
**Flexible schedule:** Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).
**Benefits package**
**Contract of Employment:** Permanent position
**Flexibility for U Program:** Hybrid
**Location:** Sant Cugat del Vallès (preferably) / Other locations as Los Angeles, Clayton or Dublin will be considered
more about Grifols
**Req ID:** 531655
**Type:** Indefinido tiempo completo
**Job Category:** I + D
This advertiser has chosen not to accept applicants from your region.
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