CSV Engineer 1307
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.
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.
CSV Engineer 1307
SimoTech require a CSV Engineer for a Pharmaceutical site based in Cork. The ideal candidate will have at least 3 years’ experience in the pharmaceutical/life sciences industry project environment.
- Preparation and review of various project and system lifecycle documents including:
- System/Project Validation Plans
- Configuration Management Plan (CMP)
- Functional and Detail Design Specification (FDS & DDS)
- Software Test Specifications
- Computer System Validation assessments
- Requirement Traceability Matrices (RTM)
- Automation Test Summary Reports (ATSM)
- Alarm Criticality Assessments
- User Requirement Specification (URS)
- DI/ERES/21 CFR Part 11 assessments
- Code Reviews
- Automation SOPs
- Working with a team of automation and software engineers.
- Liaising with Clinical Manufacturing team, CQV, Process etc.
- Test specification review.
- Review of executed test records and associated deviations.
- Review and pre-approval/post-approval of project change controls.
- 3+ years’ experience as a CSV Engineer in the Pharmaceutical or Life Sciences industry.
- Knowledge of the different phases of automation projects in GXP/GMP environments.
- Knowledge of DCS/PLC/SCADA/HMI control systems.
- Knowledge of GMAP5 and Batch S88 standards.
- Excellent communication and presentation skills.
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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