Career Category
Information Systems
Job Description
About Amgen Dun Laoghaire (ADL):
Amgen is a global biotechnology leader committed to discovering developing and delivering innovative human therapeutics. Our Dun Laoghaire site is a state-of-the-art aseptic drug product operations facility specializing in secondary manufacturing activities including Formulation Vial/Syringe Filling Lyophilisation Inspection and Packaging. We foster a culture of continuous improvement and innovation striving to improve health outcomes and ensure the continuity of supply for our medicines to over 50 countries worldwide.
About the Role:
The Sr Automation Engineer is a member of the ADL Plant Automation Team responsible for supporting drug product manufacturing maintaining automation systems in a GMP environment and implementing optimisation projects.
The role is a System Owner for critical automation assets leading troubleshooting lifecycle management and continuous improvement initiatives across multiple automation platforms.
Key Responsibilities
System Ownership & Reliability
- Act as System Owner for automation systems in a GMP-regulated manufacturing setting overseeing lifecycle maintenance and validation.
- Manage Change Controls Deviations and CAPAs associated with Automation Systems.
- Maintain robust system documentation configuration control and software versioning.
Support & Troubleshooting
- Provide on-the-floor and remote technical support to operations and engineering during production shutdowns and technology transfers.
- Lead or support incident investigations and root cause analyses for automation-related issues.
Continuous Improvement & Innovation
- Implement CAPAs including software changes and updates to design documentation and SOPs.
- Analyse current system designs and recommend improvements aligned with the latest technology and regulatory standards.
- Champion Industry 4.0 initiatives including data integration advanced analytics and digital twin technologies.
Project & Technology Integration
- Support new product or technology introductions by performing engineering assessments implementing automation system changes and supporting engineering runs.
- Work closely with cross-functional teams stakeholders and vendors to achieve common goals and deliver projects efficiently.
Safety & Compliance
- Promote a culture of safety and regulatory compliance across all activities.
- Always Ensure adherence to EHS and GMP policies.
Preferred Qualifications and Experience:
- Bachelors Degree in Automation Engineering Electrical Engineering Computer Science Chemical Engineering Biotech Engineering or related life science engineering with 5 years experience in operations/manufacturing environment.
- Background in automation design installation validation lifecycle management testing and programming.
- Experience in one the following automation specialties is an advantage:
- Biopharmaceutical Formulation or Vial/Syringe Filling
- Inspection or Packaging facilities
- Siemens and Rockwell PLC/HMI.
- iFix InTouch Zenon Process Control Systems and Rockwell FTView SCADAs.
- Fieldbus systems such as ControlNet DeviceNet Profibus ProfiNet AS-I BACnet etc.
- Knowledge of GAMP software development lifecycle ANSI/ISA-S88 and S95 industry standards 21 CFR Part 11 and Annex 11.
- Working knowledge of network architecture technologies including TCP/IP and Firewalls.
- Independent self-motivated organised and able to multi-task in a manufacturing environment.
- Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
- Solid technical writing and communication/presentation skills.
- Proficient in managing relationships with stakeholders; coordinating and collaborating with teams from different departments to achieve common goals.
- Travel at various times may be required to support training and vendor visits.
.
Required Experience:
Senior IC
Career CategoryInformation SystemsJob DescriptionAbout Amgen Dun Laoghaire (ADL):Amgen is a global biotechnology leader committed to discovering developing and delivering innovative human therapeutics. Our Dun Laoghaire site is a state-of-the-art aseptic drug product operations facility specializing...
Career Category
Information Systems
Job Description
About Amgen Dun Laoghaire (ADL):
Amgen is a global biotechnology leader committed to discovering developing and delivering innovative human therapeutics. Our Dun Laoghaire site is a state-of-the-art aseptic drug product operations facility specializing in secondary manufacturing activities including Formulation Vial/Syringe Filling Lyophilisation Inspection and Packaging. We foster a culture of continuous improvement and innovation striving to improve health outcomes and ensure the continuity of supply for our medicines to over 50 countries worldwide.
About the Role:
The Sr Automation Engineer is a member of the ADL Plant Automation Team responsible for supporting drug product manufacturing maintaining automation systems in a GMP environment and implementing optimisation projects.
The role is a System Owner for critical automation assets leading troubleshooting lifecycle management and continuous improvement initiatives across multiple automation platforms.
Key Responsibilities
System Ownership & Reliability
- Act as System Owner for automation systems in a GMP-regulated manufacturing setting overseeing lifecycle maintenance and validation.
- Manage Change Controls Deviations and CAPAs associated with Automation Systems.
- Maintain robust system documentation configuration control and software versioning.
Support & Troubleshooting
- Provide on-the-floor and remote technical support to operations and engineering during production shutdowns and technology transfers.
- Lead or support incident investigations and root cause analyses for automation-related issues.
Continuous Improvement & Innovation
- Implement CAPAs including software changes and updates to design documentation and SOPs.
- Analyse current system designs and recommend improvements aligned with the latest technology and regulatory standards.
- Champion Industry 4.0 initiatives including data integration advanced analytics and digital twin technologies.
Project & Technology Integration
- Support new product or technology introductions by performing engineering assessments implementing automation system changes and supporting engineering runs.
- Work closely with cross-functional teams stakeholders and vendors to achieve common goals and deliver projects efficiently.
Safety & Compliance
- Promote a culture of safety and regulatory compliance across all activities.
- Always Ensure adherence to EHS and GMP policies.
Preferred Qualifications and Experience:
- Bachelors Degree in Automation Engineering Electrical Engineering Computer Science Chemical Engineering Biotech Engineering or related life science engineering with 5 years experience in operations/manufacturing environment.
- Background in automation design installation validation lifecycle management testing and programming.
- Experience in one the following automation specialties is an advantage:
- Biopharmaceutical Formulation or Vial/Syringe Filling
- Inspection or Packaging facilities
- Siemens and Rockwell PLC/HMI.
- iFix InTouch Zenon Process Control Systems and Rockwell FTView SCADAs.
- Fieldbus systems such as ControlNet DeviceNet Profibus ProfiNet AS-I BACnet etc.
- Knowledge of GAMP software development lifecycle ANSI/ISA-S88 and S95 industry standards 21 CFR Part 11 and Annex 11.
- Working knowledge of network architecture technologies including TCP/IP and Firewalls.
- Independent self-motivated organised and able to multi-task in a manufacturing environment.
- Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
- Solid technical writing and communication/presentation skills.
- Proficient in managing relationships with stakeholders; coordinating and collaborating with teams from different departments to achieve common goals.
- Travel at various times may be required to support training and vendor visits.
.
Required Experience:
Senior IC
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