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.
****CSV Engineer 1642
SimoTech have an opportunity for a CSV Engineer to join our team, working on a state-of-the-art greenfield biotechnology site based in Co. Louth.
The successful candidate would have 1 - 3 years' experience working in a CSV environment within the biotechnology or pharmaceutical industry. This will be a fully onsite role.
****Key Responsibilities
* Support the creation, review, and execution of CSV documentation deliverables for DeltaV software upgrade projects.
* Assist in the validation of digitalisation platforms, including E-Signature, E-Forms, and E-Logbooks, ensuring compliance with regulatory standards.
* Participate in network integration and validation of standalone benchtop systems such as Vi-Cells, FIT analysers, Shimadzu instruments to ensure data integrity and connectivity.
* Prepare and maintain CSV protocols, test scripts, and reports for system qualification and validation activities.
* Collaborate with cross-functional teams to ensure timely completion of validation tasks and adherence to project timelines.
* Assist in troubleshooting and resolving validation-related issues during system implementation and upgrades.
* Ensure compliance with company SOPs, industry standards, and regulatory guidelines throughout all validation activities.
* Maintain accurate documentation and support audits by providing validation evidence as required.
Qualifications
Requirements
**Qualifications & Experience
* Bachelor's degree in Engineering, Computer Science or Life Sciences.
* Minimum 1 year of relevant validation experience within the biotechnology or pharmaceutical industry.
* Solid understanding of regulatory compliance requirements in a pharmaceutical environment.
* Good knowledge of digital platforms such as E-Signature, E-Forms, and E-Logbooks.
* Hands-on experience in validation of standalone benchtop systems.
* Proficiency in using quality systems for documentation and compliance.
* Demonstrate accuracy and attention to detail, combined with strong planning and organisational skills to manage documentation control, execute tasks, and adapt to changing priorities.
Benefits
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****