Alexion Pharmaceuticals Automation Applications + Infrastructure Engineer in Ireland
- This position is based at the Alexion facility in Blanchardstown, Dublin. The Automation Applications & Infrastructure Engineer shall be responsible, as part of the client team, for the development, management & optimisation of the Manufacturing Systems in ADMF.
Principal Responsibilities (file://humanresources/DavWWWRoot/glblvl/Global%20Leveling%20Criteria/Position%20Description%20Guide%20-%20ALXN%20(2.2).docx)
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 our in-house Automation team, to develop, manage & optimize manufacturing systems in the Alexion Dublin Manufacturing Facility (ADMF).
Ensure standardization and best practice through co-operation and alignment with other manufacturing plants in Alexion’s 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 cybersecurity for manufacturing systems. Evaluate corporate-standard and manufacturing-specific technologies for suitability to robust the manufacturing environment. Support regular external consultant assessments of cybersecurity.
Provide remote support to our sister facility in Athlone (AAMF).
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.
5 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 a deep knowledge of industrial environment system architectures.
Ability to constructively challenge, defend and present technical aspects of system design.
Demonstrated capability for supporting 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.
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.
Full 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.
B.S. Degree in Engineering/Computer Science or equivalent
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.