SKILLS BRIEF

• Strong lab systems validation experience is essential and experience in any of the following – equipment validation, computer systems validation (CSV), process validation would be highly beneficial
• Ability to work in a cross functional/matrix team environment is required
• At a sufficient level of expertise to take front line interactions with the customer for assigned project work and possess the ability to report to management on progress and any roadblocks that present themselves over the course of the work
• Change management and project management experience in an FDA regulated environment is preferred
• Must possess excellent oral and written communication skills, including the ability to advise and influence
• Strong understanding of data integrity and ALCOA+
• Strong understanding of Windows Security, and Active Directory and how these can be leveraged to ensure data security.
• Through practical knowledge of 21 CFR Part 11, Annex 11 and PIC’s regulatory requirements is a must.

THE ROLE

• LIMS Validation Engineer
• Sligo
• Onsite role
• Permanent or Contractor Opportunity

ROLE BRIEF

The successful candidate will focus on supporting an upgrade to SampleManager LIMS for 2025. The role will have a number of deliverables across a variety of teams and play a key part in the translation of functional and business requirements into detailed technical requirements which are used to document and develop solutions.

SOME KEY RESPONSIBILITIES:

• Support the client across a major LIMS (SampleManager) upgrade project
• Support the client with Lab systems validation requirements
• Support CSV Deliverables generation, testing, reviewing, training & end-user support for production use
• Support training/mentoring of junior level IT Staff/Project Core Team
• Assist with requirements elicitation workshops/sessions with R&D Laboratory End-Users
• Assist with project planning/scoping discussions with requirements output
• Generating Change Controls under GxP guidelines
• Support GxP IT Change Control Process with any maintenance support activities with production Go-Live of LIMS and/or other systems
• Liaison with QC & RD Lab, Quality, IT & Validation to meet system requirements