Lab CSV -IT/OT Engineer - Dublin - 12 mth Contract
Excellent contract opportunity for an experienced Lab CSV-IT/OT Engineer to join our client a long-established biopharmaceutical products manufacturer at their Dublin based facility
The Lab CSV-IT/OT Engineer will be responsible for all IT/OT aspects of Laboratory and production IT systems and associated infrastructures
Provide front line support for operational issues, asset replacement, system upgrades on all Laboratory and Production OT systems including Empower, Karl Fisher, Pharmasuite.
Manage, develop, follow, and enforce processes and procedures for Laboratory and Production OT systems to ensure a consistent and reliable OT service to our customers.
Execute Periodic Reviews, Data Integrity Assessments, System Impact Assessments, Cyber Security Risk Assessments, Remediation, Backups, etc, to ensure compliance, business continuity, and the qualified status of the Laboratory and Production OT systems.
Drive a culture of continuous improvement and standardisation.
Build and/or maintain a system of quality GxP documentation.
Provide OT technical guidance and support as required to ensure delivery of projects into the Labs and Production Systems.
Act as Subject Matter Expert for Lab and Production OT systems for both internal and external audit.
Support Global Empower System and future additions to the system.
OT Printer management and support - Vendor SLA management
MES Application IT Administration - Rockwell Pharmasuite.
Act as additional support to OT team with shared responsibilities for all IT/OT infrastructures and Cyber Security:
Support local IT/OT infrastructures - Computer room(s), Network equipment, OT Servers Workstations, printers, and scanners.
Site Support for: Lab and Production OT Systems
Act as subject matter expert for Laboratory and Production OT systems for both internal and external audit.
Front line support for breakdowns and operational issues with site OT systems.
Troubleshoot Operating System and Software issues if required.
Provide technical hardware, software and coding expertise
Establish appropriate maintenance strategies for individual Laboratory / Production OT systems
Support the Engineering Maintenance function to ensure that all Laboratory / Production OT systems are maintained
Ensure robust obsolescence strategy in place for site Laboratory / Production IT systems.
Manage miscellaneous small / medium projects for use in a GLP environment according to GAMP 5 and CFR 21, which will include management & coordination of project definition, design, purchasing, installation, commissioning & qualification of equipment.
Act as technical point of contact for Laboratory and Production OT systems for Capital Projects.
Contribute to development, implementation, and maintenance of a Good Engineering Practice platform
Proactively engage with Quality and Laboratory teams to encourage the use of technology
Knowledge, Abilities & Experience
Bachelor s Degree in Engineering, Information Systems, Computer Science, Life Sciences, or related field
3 years hands-on experience providing Lab IT systems support (Empower etc) in biotec or pharma industries.
2 years hands-on experience with CSV activities within a regulated Industry.
At least 1 years hands-on experience with MES application IT Administration support.
Knowledge of EU cGMPs, FDA, Annex 11/21CFR Part 11, GAMP 5 and Data Integrity Guidelines.
Experience in supporting infrastructures and applications; or equivalent position.
Windows servers management and administration (Win (Apply online only) and higher)
Virtualization technologies (VMWare, ESX)
Inventory and Configuration management
Backup technologies and Business Continuity Planning (BCP)/Disaster Recovery Planning (DRP) knowledge
Databases administration knowledge (SQL, Oracle)
Knowledge of regulatory requirements (EU cGMPs, FDA, Annex 11 / 21CFRPart 11, GAMP5)
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