Lab IT CSV Engineer 1658

Whatis it like to work at SimoTech? With a strong collaborative teamworkculture based on respect, trust, and excellence, we play a criticalpartnering role to our clients' life-changing supply of products topatients. In return, there is excellent salary, benefits, careerprogression, educational support andmuch more.

SimoTech has a new opportunity for an engineerwith 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 workingmodel.

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 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.

What SimoTech CanOffer

• 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-disciplinary environment.
• Opportunity to work with large corporate clients.