Réalta Technologies are currently searching for a Labs CSV Engineer with 3+ years' experience to support a Pharmaceutical client of ours with a variety of computerised instrument systems across both laboratory and manufacturing operations at their pharmaceutical manufacturing facility in Cork.
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:
* 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.