CSV Engineer
- Dublin
- Contract
- CAPEX Projects
This vacancy has now expired
Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’ lives? Our client, a globally renowned biotechnology organisation, and voted one of the top 10 best companies to work for in Ireland, is looking to recruit a CSV Engineer to join their team.
Responsibilities:
- Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
- Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
- Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
- Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
- Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
- Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.
- Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.
Requirements:
- Bachelor's degree in Computer Science, Engineering, or a related field.
- Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
- Familiarity with validation methodologies, including risk-based validation approaches.
- Proficiency in creating and executing validation protocols and documenting validation activities.
- Excellent analytical and problem-solving skills, with attention to detail.
- Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
- Ability to work independently and manage multiple projects simultaneously.
- Knowledge of software development life cycle (SDLC) and change control processes.
- Understanding of data integrity principles and practices.
If this role is of interest to you, please apply now!
#LI-JS4
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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