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.
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.
Intermediate Lab CSV IT Engineer
SimoTech is seeking an Intermediate Lab IT CSV Engineer to support our biopharma client in Co. Cork Working closely with the project team, you will support the planning and delivery of validation activities across a range of systems and business initiatives.
This role involves contributing to validation documentation, ensuring compliance with relevant quality and regulatory standards, and working with stakeholders to maintain validated and compliant system environments.
Key Responsibilities
- Support the execution of CSV deliverables for laboratory computerised systems throughout their lifecycle.
- Assist with equipment categorisation, risk assessments, and validation planning activities.
- Generate, review, and execute validation documentation, including protocols and reports, in accordance with regulatory and site requirements.
- Support the implementation and validation of system upgrades, enhancements, and change controls.
- Assist with the integration of laboratory systems into the wider IT infrastructure while maintaining compliance standards.
- Participate in deviation investigations and help ensure issues are documented and resolved appropriately.
- Collaborate with QA, IT, business users, and vendors to deliver project milestones and maintain validated system states.
- Support audit readiness activities by maintaining accurate validation and traceability documentation.
- Troubleshoot system and validation-related issues and contribute to continuous improvement initiatives.
- Adhere to EHS and Quality requirements and actively contribute to team objectives.
Key Requirements
- Bachelor's degree in Engineering, Computer Science, or a related technical discipline.
- Minimum 3-5 years' experience in Computer System Validation within a regulated pharmaceutical, biotechnology, or laboratory environment.
- Working knowledge of GxP systems, 21 CFR Part 11, Data Integrity principles, and validation best practices.
- Experience supporting validation activities for laboratory computerised systems and generating SDLC documentation.
- Familiarity with system upgrades, change control processes, and risk-based validation approaches.
- Understanding of laboratory system integrations and interactions with enterprise IT infrastructure.
- Proficiency with Microsoft Office applications and general software configuration and troubleshooting.
- Strong communication and stakeholder engagement skills, with the ability to work effectively within cross-functional teams.
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 on exciting capital projects.
SimoTech