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.
Lab IT CSV Engineer 1607
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 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 working model.
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 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
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 a proven ability to communicate and build relationships cross-functionally.
Benefits
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