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Urgent! Lab IT CSV Engineer 1607 Job Opening In Kinsale – Now Hiring SimoTech

Lab IT CSV Engineer 1607



Job description

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 1607


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 3rd 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 a 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





Required Skill Profession

Computer Occupations



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