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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.
CSV Engineer 1404
SimoTech require a CSV Engineer to work with our client, a global leader in medical technology, on a global capital project. Reporting to the Project lead the successful Engineer will be a key member of the team focused on expansion and transformation of global operation.
The main purpose of this role will be to manage qualification of the GxP Computerised Systems involved in the plant expansion and improvement projects, including but not limited to Utilities System(s) / BMS changes and installations of packaging & filling equipment.
Key Responsibilities
- Work closely with other engineering disciplines & vendors of equipment to ensure deliverables meet qualification requirements.
- Ensure computer system validation including its associated documentation is performed in a manner that is fully compliant with site specific policies and regulations, good manufacturing practices and industry regulations.
- Develop and execute Change Controls and Trackwise records for relevant system updates / changes in accordance with site procedures and industry standards.
- Prepare, and execute where required, GXP system documents including validation plans, requirements specifications, risk assessments, qualification protocols, requirements traceability matrices, data lifecycle maps, and validation reports.
- Set up of GXP System specifications and Standard Operating Procedures (SOPs) to align with industry standards.
- As required attend system Factory Acceptance Tests in Ireland or abroad.
- Working withing a collaborative environment, ensure that key commitments and milestones are delivered on time.
- Ensure all project work is completed in compliance with all regulatory requirements, procedures, and guidelines, and execute cGMP in the performance of day-to-day activities across all applicable job functions.
Qualifications
- Relevant 3rd level qualification.
- Minimum of 3-4 years’ experience in biotech/pharmaceutical industry qualifying GXP systems.
- Significant project lifecycle experience in CSV validation of GXP systems is essential.
- Good understanding of regulatory requirements as they relate to GXP system qualification and data management best practices.
- Experience delivering a complete suite of validation documentation relating to GXP control system introductions / changes.
- Excellent verbal and written communication skills.
- Strong analytical problem-solving 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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