Junior Lab CSV IT Engineer 1736

SimoTechnology; Cork; On-site; EUR 40,000 - 60,000; Full time

Job summary

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

You will assist in implementation, validation, and ongoing support of laboratory computerized systems, working with CSV, Quality, and IT professionals in a GMP environment to gain hands-on experience across system lifecycle activities.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related technical discipline.
• 1-3 years' experience in a regulated pharmaceutical, biotech, medical device, or lab environment.
• Basic understanding of CSV, SDLC, and GMP principles.
• Strong attention to detail and documentation skills.
• Good communication and teamwork abilities.
• Exposure to validation documentation and testing activities is advantageous.

Responsibilities

• Support validation activities for laboratory computerised systems under supervision.
• Assist with preparation and execution of validation protocols and test scripts.
• Contribute to generation and maintenance of validation documentation.
• Participate in risk assessments, change controls, and document reviews.
• Support collection and organisation of validation evidence and test records.
• Assist with system periodic reviews and compliance monitoring activities.
• Coordinate with laboratory, quality and IT teams to resolve validation issues.
• Support inspection and audit readiness activities.
• Coordinate system and test data availability with laboratory teams.
• Ensure work adheres to GMP, Data Integrity, and company procedures.

Skills

Documentation skills

Attention to detail

Team collaboration

Good communication

Willingness to learn

Education

Bachelor's degree in Engineering/Computer Science or related technical discipline

Tools

LIMS

CDS

ELN

LabVantage

Job description

What is it like to work at SimoTech? With astrong collaborative teamwork culture based on respect, trust and excellence,we play a critical partnering role to our clients’ life-changing supply ofproducts to patients. In return, there is excellent salary, benefits, careerprogression, educational support and much more.

SimoTech is seeking a Junior Lab ITCSV Engineer to support laboratory system validation and compliance activitiesfor our biopharma client in Co. Cork.

In this role, you will support theimplementation, validation, and ongoing support of laboratory computerisedsystems while working alongside experienced CSV, Quality, and IT professionals.You will gain hands-on experience across system lifecycle activities, contributingto projects that support the development and manufacture of life-changingmedicines within a highly regulated GMP environment.

This is an excellent opportunity toaccelerate your career, develop valuable technical and compliance knowledge,and make a meaningful impact from day one.

KeyResponsibilities

• Support validation activities for laboratory computerised systems underthe guidance of senior team members.
  
• Assist with the preparation and execution of validation protocols andtest scripts.
  
• Contribute to the generation and maintenance of validationdocumentation.
  
• Participate in risk assessments, change controls, and document reviews.
  
• Support the collection and organisation of validation evidence and testrecords.
  
• Assist with system periodic reviews and compliance monitoringactivities.
  
• Work with Laboratory, Quality, and IT teams to resolvevalidation-related issues.
  
• Support inspection and audit readiness activities.
  
• Coordinate system and test data availability with laboratory teams tosupport test execution.
  
• Ensure work is completed in accordance with GMP, Data Integrity, andcompany procedures.
  

Requirements

Key Requirements

• Bachelors degree in Engineering, Computer Science, or a relatedtechnical discipline.
  
• 1-3 years' experience in a regulated pharmaceutical, biotechnology,medical device, or laboratory environment.
  
• Basic understanding of CSV, SDLC, and GMP principles.
  
• Strong attention to detail and documentation skills.
  
• Good communication skills and willingness to learn.
  
• Ability to work collaboratively within cross-functional teams.
  
• Exposure to validation documentation and testing activities isadvantageous.
  
• Familiarity with laboratory systems such as LIMS, CDS, ELN, LabVantage, orsimilar platforms is desirable.

What SimoTech CanOffer

• Role provides a high degree of autonomy to allow the successfulcandidate to reach their full potential.
  
• Develop new skills and enhance technical ability by working withinnovative technologies in a multi-disciplined environment.
  
• Opportunity to work with large corporate clients on exciting capitalprojects.