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Senior IT Principal Engineer- Laboratory Systems

  • Sector: IT
  • Contact Email: gillian.nicholson@collinsmcnicholas.ie
  • Job Ref: 20616

We have an exciting opportunity for an Senior IT Principal Engineer- Laboratory Systems

This person will be responsible for the successful management and execution of all the IS activities supporting Quality and Laboratory information systems and will also lead the implementation of new Quality and Laboratory information systems and management of 4 team members. The ideal candidate will have strong LAN, Windows Server, VMware, Citrix, AD, Domain Controls, IAM and Security experience.

Responsibilities Include:

  • Act as the Team lead for Information Systems supporting Quality and Laboratory information equipment.
  • Ownership and administration of the IS aspects of Lab equipment – including analytical equipment platform architecture, system ownership and lifecycle management.
  • Ensure that all Lab IT systems and Benchtop Analytical Equipment meet 21 CFR 11 and EU Annex 11 compliance requirements.
  • Lead a team of QC Lab Systems IT engineers.
  • Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and QC analytical personnel.
  • Ensure that all associated protocols/reports are completed, reviewed and approved within agreed timelines in order to secure reliable, consistent & compliant operation of all Lab Equipment\Instruments to meet the GMP and business requirements of the labs.
  • Lead technical root cause analysis, incident investigations and troubleshooting issues related to the Quality and Laboratory information systems.
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
  • Support new technology introductions by performing IS assessments and implementing IS system configuration changes.
  • Participate in Computer Software Validations.

Experience Required:

  • University degree in related Science/IT/Quality discipline or relevant qualifications required.
  • At least 3 years’ experience supporting Quality and/or Laboratory information systems in the biotechnology or pharmaceutical industries or has worked in similar Laboratory environments and has gained expertise in the use of Laboratory information systems.
  • Experience with any the following systems would be an advantage: Chromatography (Empower – Waters), Lab Data Archival (Nugenesis – Waters), Electronic Methods Execution/Electronic Lab Notebook (SmartLab – Biovia) LIMS (Sample Manager - ThermoFisher)
  • Experience of the following: Windows 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.
  • Technical leadership skills with a strong ability to support continuous improvement initiatives. Previous experience in a Quality Control/GMP environment is required.
  • Experience with LIMS and Empower is desirable.
  • ICH and GMP guidelines desirable in relation to Lab IT requirements.
  • Experience with regulatory/customer audits is desirable.

*Full job spec available upon request*

For a confidential discussion about this opportunity please contact Gillian Nicholson

gillian.nicholson@collinsmcnicholas.ie

090 6450665 (01 6620088)