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Lab IT CSV Engineer 1432
Cork
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, career progression, educational support and much more.
Lab IT CSV Engineer 1432
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 in a hybrid role, as part of our client’s Computerised Instruments team, supporting a variety of computerised instrument systems across laboratory and manufacturing operations in their state-of-the-art pharmaceutical manufacturing facility in Cork.
The ideal candidate will have at least 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 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.
Qualifications
- 3 to 5 years’ experience supporting IT Applications including validating laboratory computerised systems. This includes experience 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.
- Strong interpersonal and communication skills are required, with proven ability to communicate and build relationships cross-functionally.
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.
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