Automation Applications & Infrastructure Engineer - Tandem Project Management

Summary:
The Automation Applications & Infrastructure Engineer shall be responsible, as part of the client team with a Bio pharmaceutical company based in Athlone, for the development, management & optimization of the Manufacturing Systems.

Responsibilities:

• Support critical-to-manufacturing systems and ensure their high availability reducing or eliminating unplanned downtime.
• Provide subject matter expertise in the design and implementation of new or upgraded technologies within the manufacturing environment.
• Ensure compliance of manufacturing systems; including robust SOPs, backup/restoration of manufacturing data and management of user access to GMP systems.
• Work independently, or give guidance to the in-house Automation team, to develop, manage & optimize manufacturing systems in the manufacturing facility.
• Ensure standardization and best practice through co-operation and alignment with other manufacturing plants in network.
• Work closely with the corporate IT infrastructure team to ensure continued technical alignment.
• Manage support for manufacturing dependencies and touchpoints with enterprise systems.
• Responsibility for defining and implementing the maintenance of all manufacturing system assets.
• Ensure appropriate monitoring, alerting and response to network and system issues affecting functionality and availability.
• Manage level of availability of internal and external support for manufacturing system software and server hardware.
• Develop plan for system obsolescence, vendor support and upgrade scheduling.
• Evaluate risks, estimate requirements and ensure inclusion in annual and long-term capital planning.
• Develop business continuity plans and procedures to ensure adequate spares and timely response to system issues and failures.
• Maintain relationship with critical suppliers, managing escalation and resolution of technical issues.
• Provide expertise to the engineering and operations department on design and sustaining decisions.
• Liaise closely with internal stakeholders to successfully support manufacturing operations
• Work closely with corporate Global Security to manage cyber security for manufacturing systems.
• Evaluate corporate-standard and manufacturing-specific technologies for suitability to robust the manufacturing environment. Support regular external consultant assessments of cyber security.
• Manage scheduling, implementation and reporting of preventative maintenance, patching & upgrades on the Manufacturing Systems network.
• Provide system support to cross-functional teams driving optimization of processes and equipment.
• Grow Automation Applications & Infrastructure skills & capabilities within the Manufacturing team.
• Assist in training personnel on specific aspects of Manufacturing Systems
• Design and implement solutions across automation platforms in line with the site change control procedures
• Support NPI projects and other future on site projects.

Qualifications & Experience:

• B.S. Degree in Engineering/Computer Science or equivalent.
• 4 - 6 years or more IT Applications & Infrastructure experience.
• 2 years or more supporting GMP environments and applications.
• Strong knowledge of Virtualization (incl. VMWare & Hyper-V) in an operational environment.
• Has knowledge of industrial environment system architectures.
• Ability to constructively challenge, defend and present technical aspects of system design.
• Demonstrated capability for leading complex IT projects technically from initial design / development through to the validation of the facility in support of defined objectives.
• Direct experience in supporting a manufacturing facility.
• Experience of implementing change controls and investigating system deviations/events.
• Experience of system integration using Ethernet, Profibus & other industrial interfaces.
• Experience with SQL Server is a necessity; experience of OSIsoft Pi is a plus.
• Understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices (GAMP) to ensure site automation systems are cGMP compliant.
• Understanding of automation system implementation and validation life cycle along with an understanding of the product quality impact of changes.
• Good interpersonal skills are required, as is the ability to communicate well, both verbally and through written documents.