North Leinster  

About SimoTech

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.
 

Why SimoTech

What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, career progression, educational support and much more.
 

Manufacturing Benchtop Equipment IT Team Lead 1416

SimoTech requires an experienced Manufacturing Benchtop Equipment (“MFG BTE”) IT Team Lead for a biologics client in North Leinster. The MFG BTE IT Team Lead will be responsible for ensuring reliable, robust, and compliant Benchtop IT systems to meet business requirements including supporting integration to other systems. They will manage the day-to-day routine administrative processes to ensure the computer system instruments are maintained in accordance with site protocols and GMP compliance. They will oversee a team of MFG BTE IT support technicians and work with them to resolve any technical issues that may arise. The successful candidate must be self-motivated to lead the development of routine processes and procedures and strives to take initiative to drive process improvement. SimoTech is seeking a candidate that can not only manage projects and coordinate teams, but also embodies a can-do attitude to problem solve. This is a high-performance role within an exciting start-up biologics environment. The successful candidate must be experienced in working with benchtop instruments within operational cleanroom environments. This role is based on site full-time.

Key Responsibilities

• You will work under the direction of the Manufacturing Systems Group, site leadership and engage with other manufacturing team members.
• Manage the day-to-day activities of the MFG BTE IT Support Team to maintain the operational and validated state of all MFG BTE GMP IT systems.
• Manage and coordinate routine instrument GMP data back-ups with the MFG IT technicians.
• Set task priorities based on client needs and routing preventative maintenance requirements.
• Handle ongoing user access requests and manage resolution of any technical issues relating to user access.
• Provide technical support to the network integration project.
• Ensure a fast response to all problems reported to ensure highest level of instrument uptime and - when necessary - ensure timely escalation of unresolved technical GMP IT issues.
• Ensure that all MFG BTE GMP IT systems meet 21 CFR 11 and EU Annex 11 compliance requirements.
• Interfacing with Vendors on technical matters and coordinating routine maintenance activity.
• Participation in periodic reviews of SOP.
• Support the Calibrations Team with maintaining adequate instrument spare parts.
• Platform strategy development for all MFG BTE GMP IT systems, including defining and maintaining the systems roadmap.
• Responsible for regular communication to site leadership & multi-functional team stakeholders.
• Assures all work is completed in compliance with all Regulatory requirements including, Quality (cGLP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local/Federal Regulatory requirements.

Qualifications

• Bachelors or Master’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
• At least 8 years’ experience providing GMP Lab IT systems solutions and support to manufacturing organisations in the biotechnology or pharmaceutical industries.
• Experience of the following: Windows Server 2000, 2003, 2008, 2012, Windows NT, 98, XP, Win 7, MS Active Directory, DNS, DHCP, DFS, MS Office 2003/2010/2013, MS Office Communicator, MS Lync 2010/2013, MS SharePoint 2007/2010, LAN/WAN/VPN.
• Experience with the following systems would be an advantage: Filter Integrity Testers, Blood Gas Analysers, Spectrophotometers, Cell Viability Analysers.
• Strong knowledge of databases, reporting and analytic systems.
• Strong communication skills. Problem solver with a focus on achievement of overall project goals.
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilising technical, project management, and business expertise.

What SimoTech Can Offer

• Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
• Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
• Opportunity to work with large corporate clients on exciting capital projects.

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