Lab IT CSV Engineer 1607

Why SimoTech

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 clients 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 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