Data Integrity Systems Engineer

Data Integrity Systems Engineer – Team Horizon

 

We are currently recruiting a Data Integrity Systems Engineer to join the Dublin team for our client, who are a global, research-based biopharmaceutical company. Joining the Business Technology Solutions Team, you will work with counterparts in Manufacturing, QA, and Engineering departments. This role is central to the digital transformation of the client’s OSD site with key focus on data integrity. A key aspect of the role with require a strong focus on adhering to Data Integrity and Data Security controls for all manufacturing systems at the site.

 

Working closely with the Automation Process Control systems team on all aspects of data integrity for all software components installed or being implemented within the Manufacturing plant. Additional responsibilities will include adhering to change control/management, configuration control, compliance to system security policies and data integrity along with coordinating systems patched, backups, and user management strategy.

 

Why you should apply:

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  Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.


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  The role is generously compensated and attracts a competitive base salary and highly attractive benefits package.


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  Excellent career progression opportunities.

 

What you will bedoing:

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  Play a key role in the digital transformation and strategy of the client’s OSD site ensuring all transformation follows best practise data integrity principles.


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  Provide leadership from a data integrity perspective on control systems and IT systems used on manufacturing shopfloor.


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  Following Data Integrity and Data Security policies and procedures for Control Systems and IT Systems on the manufacturing shopfloor, ensure systems are adherent to policies.


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  Execute strategy to enable compliant systems backup and restores, patching, data archiving, and user accounts management. Where automated controls are not possible, ensure procedural controls are in place to strengthen Data Integrity and Data Security.


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  Provide data integrity support on all Process Control Systems and IT Manufacturing Systems in Dublin Manufacturing Plant.


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  Support implementation, qualification, and maintenance of manufacturing IT systems (MES, Data historian, HMIs, PLCs, IPC, etc) and associate IT infrastructure that delivers operational efficiency and agility.


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  Generate & Maintain documentation (SOP’s & Technical Documentation) for full GMP validation and operation, including documentation of changes made.


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  Maintain Data Integrity and Data Security Program, including remediation of legacy systems to ensure robust procedure and systems are in place covering data integrity, security and recovery


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  Contribute to the Automation & IT Business Strategy


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  Define business continuity methods for IT element of manufacturing processes

 

What you need to apply:

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  Relevant degree in information technology, Computer Science, Engineering, Mechatronics, or similar with demonstrated working knowledge of POMSnet and/or other Manufacturing Execution systems to support OSD processes.


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  3 years technical experience in manufacturing systems, process automation, with relevant experience of batch processing SCADA Systems and DCS platforms in a GMP environment in the pharmaceutical industry desired


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  Data integrity experience with automation systems by Siemens, Allen-Bradley, and Honeywell desired


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  3 years’ experience of the 21 CFR Part 11 requirements for manufacturing systems in the pharmaceutical industry.


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  Computer Systems Validation experience 


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  Ability to work well under pressure, multi-task and meet deadlines


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  Experience with OSI PI/data historian an advantage


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  Broad knowledge of MS operating system, including server roles: AD, DNS, Virtualization, Remote Desktop, etc.


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  Programming skills are desirable