CSV Engineer 1642

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 1642            

SimoTech have an opportunity for a CSV
Engineer to join our team, working on a state -of -the -art greenfield
biotechnology site based in Co. Louth.

The successful candidate would have 1 - 3
years’ experience working in a CSV environment within the biotechnology or
pharmaceutical industry. This will be a fully onsite role.

Key Responsibilities

• Support the creation, review, and execution of CSV
  documentation deliverables for DeltaV software upgrade projects.
  
• Assist in the validation of digitalisation platforms,
  including E -Signature, E -Forms, and E -Logbooks, ensuring compliance with
  regulatory standards.
  
• Participate in network integration and validation of
  standalone benchtop systems such as Vi -Cells, FIT analysers, Shimadzu
  instruments to ensure data integrity and connectivity.
  
• Prepare and maintain CSV protocols, test scripts, and
  reports for system qualification and validation activities.
  
• Collaborate with cross -functional teams to ensure
  timely completion of validation tasks and adherence to project timelines.
  
• Assist in troubleshooting and resolving
  validation -related issues during system implementation and upgrades.
  
• Ensure compliance with company SOPs, industry
  standards, and regulatory guidelines throughout all validation activities.
  
• Maintain accurate documentation and support audits by
  providing validation evidence as required.
  

Requirements

Qualifications &
Experience

• Bachelor’s degree in Engineering, Computer Science or
  Life Sciences.
  
• Minimum 1 year of relevant validation experience
  within the biotechnology or pharmaceutical industry.
  
• Solid understanding of regulatory compliance
  requirements in a pharmaceutical environment.
  
• Good knowledge of digital platforms such as
  E -Signature, E -Forms, and E -Logbooks.
  
• Hands -on experience in validation of standalone
  benchtop systems.
  
• Proficiency in using quality systems for documentation
  and compliance.
  
• Demonstrate accuracy and attention to detail, combined
  with strong planning and organisational skills to manage documentation control,
  execute tasks, and adapt to changing priorities.
  

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