ABOUT SIMOTECH

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.

QUALIFICATIONS

• 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.

• 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.