CSV Engineer 1679

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.

CSV Engineer 1678

SimoTech are seeking a Labs CSV Engineer to
support a pharmaceutical client based in Co. Louth. Working under the direction
of the site Process Equipment Validation (PEV) team, the successful candidate
will provide hands‑on
validation and technical support for laboratory equipment and Lab IT systems
across the project lifecycle.

The role will focus on delivering risk‑based validation
activities, including Data Integrity / ERES assessments, review of vendor
validation documentation, and support of deviations, impact assessments, and
change control activities.

The ideal candidate will have a minimum of 5
years’ experience within the pharmaceutical industry, delivering compliant CSV
support for laboratory or manufacturing systems in line with regulatory and
data integrity requirements.

Key Responsibilities

•   Work under the direction of the site Engineering
  team, providing hands‑on
  validation and technical support for manufacturing benchtop equipment.
  
• Support the rollout of networking functionality to a
  range of benchtop instruments across a variety of instrument families.
  
• Lead and execute risk assessments prior to test
  execution, including Data Integrity / ERES assessments and functional risk
  assessments, applying sound judgment appropriate to system criticality.
  
• Review, assess, and leverage vendor validation
  documentation, including protocols, test evidence, and validation summary
  reports, to support a risk‑based validation approach.
  
• Participate in and support deviation
  investigations, impact assessments, root cause analysis, and change control
  activities, providing technical input and recommendations.
  
• Contribute to and, where appropriate, take
  ownership of project deliverables, including design documentation,
  configuration/build, installation support, and validation execution (IQ/OQ/PQ
  or equivalent).
  
• Act as a key technical interface with vendors, IT,
  QA, and manufacturing stakeholders, ensuring alignment with site standards and
  project expectations.
  
• Provide clear, timely communication to project
  leadership and stakeholders on status, risks, and issues.
  
• Ensure all activities are performed in compliance
  with applicable regulatory and internal requirements, including cGLP/cGMP, EHS,
  Global Engineering standards, design and construction directives, and relevant
  local and federal regulations.
  
  
  

Requirements

Qualifications &
Experience

•  Bachelors
  or Master’s Degree in Engineering, Life Sciences, Computer Science.
  
• At
  least five years’ CSV experience, including a minimum of two years supporting
  systems in a labs or manufacturing environment.
  
• Experience
  of the validation of the following instruments: Filter Integrity testers, Vi -Cell,
  Solo VPE etc.
  
• Experience
  with the networking of IT equipment would be an advantage.
  
• Significant
  knowledge of regulatory requirements relating to CSV and Data Integrity
  including 21 CFR
  Part 11 / EU Annex 11.
  

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