Lab CSV IT Engineer 1735

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, benefits, career
progression, educational support and much more.  

Lab CSV IT Engineer 1735

SimoTech is seeking a Lab IT CSV
Engineer to support laboratory system validation and compliance activities for
our biopharma client in Co. Cork.

In this role, you will contribute
to the implementation, validation, and ongoing support of laboratory computerised
systems, partnering with cross-functional stakeholders to ensure systems remain
compliant, reliable, and fit for purpose.

You will play an active role in
system lifecycle activities, support continuous improvement initiatives, and
help deliver solutions that enable the development and manufacture of
life-changing medicines within a highly regulated GMP environment.

Key
Responsibilities

• Support the planning, execution, and review of CSV deliverables for
  laboratory systems.
  
• Perform equipment categorisation and assist with effort estimations.
  
• Execute validation activities for new and existing laboratory computerised
  systems.
  
• Author, review, and maintain SDLC and validation documentation including
  URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and
  Validation Reports.
  
• Support system integrations and ensure compliance with IT and
  cybersecurity requirements.
  
• Participate in change control, deviation investigations, CAPA
  activities, and periodic reviews.
  
• Assist with audit preparation and provide support during internal and
  external inspections.
  
• Collaborate with Quality, Laboratory, Engineering, and IT teams to
  ensure compliance with GxP regulations.
  
• Communicate project progress, risks, and issues to project leads and
  stakeholders.
  
  

Requirements

Key Requirements

• Bachelors degree in Engineering, Computer Science, or a related
  technical discipline.
  
• 3-5 years' experience in Computer System Validation within GMP-regulated
  environments.
  
•  Working knowledge of GxP systems, 21 CFR Part 11, Annex 11, and Data
  Integrity principles.
  
• Experience generating and executing validation documentation.
  
• Exposure to laboratory systems such as LIMS, CDS, Empower, ELN, LabX,
  LabVantage, or similar platforms.
  
• Good understanding of system lifecycle management and quality systems.
  
• Strong communication and stakeholder engagement skills.
  
• Ability to work independently while supporting larger project teams.
  

Benefits

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.