Lab IT CSV Engineer 1647

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 IT CSV Engineer 1647

SimoTech
has a new opportunity for an engineer with 3+ years’ experience in Computer
Systems Validation and Laboratory IT systems to join our team. The successful
candidate will work as part of our client’s Computerised Instruments team, supporting
a variety of computerised instrument systems across laboratory and
manufacturing operations at their state -of -the -art pharmaceutical manufacturing
facility in Cork. The role has a hybrid working model.

The
ideal candidate will have a minimum of 3 years’ experience in a similar role
within a GMP / GxP environment, ensuring computerised instrument systems meet
all data integrity, cyber security, quality, lifecycle management and
regulatory requirements.

Key Responsibilities

• Manage
  and coordinate the Lab System CSV deliverables for new and existing projects
  from initiation to release, prioritising support activities in line with
  project schedules.
  
• Generate
  validation documentation in accordance with site procedures and regulatory
  guidelines, including but not limited to, 21 CFR Part 11, EU GMP Annex 11, and data
  integrity guidelines.
  
• Work closely with 3^rd parties to install
  computerised instrument solutions, ensuring correct configuration to successfully
  integrate with existing onsite IT services and infrastructure.
  
• Initiate and implement Change Control activities in
  accordance with quality standards and practices.
  
• Follow
  all relevant EHS procedures and assist in incident investigations as required.
  
•  Recognise
  the importance of the quality control function in pharmaceutical
  production. 
  
• Actively participate and contribute to team
  meetings.
  
  

Requirements

Qualifications &
Experience

• 3+
  years’ experience supporting IT Applications including validating laboratory computerised
  systems, writing validation plans, requirements gathering, design
  documentation, system configuration, system testing and troubleshooting.
  
•  Experience implementing
  changes for IT applications in a GMP environment.
  
• Knowledge of 21 CFR Part 11
  and data integrity guidelines.
  
• Experience with MS Office and
  software installation knowledge.
  
• ​Strong interpersonal and
  communication skills are required, with proven ability to communicate and build
  relationships cross -functionally.
  

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