Job Description
Due to continued expansion of their operations our client a well-established Multinational Healthcare Manufacturer now require a qualified and experienced CSV Engineer
The Computer Systems Validation Engineer is responsible for implementation of the Site Validation Policy as well as compliance with regulations and current industry standards. Liaising with system owners and key stakeholders to support the validation of both laboratory and manufacturing computerised systems.
This is a permanent role based in Dublin with a good salary and benefits package.
Key Responsibilities of CSV Engineer:
- Preparation, review and/or approval of both laboratory and manufacturing based computerised system validation lifecycle documentation.
- Assessment of both laboratory and manufacturing systems against Data Integrity, EU Annex 11 and 21 CFR Part 11 requirements.
- Preparation of action or remediation plans for each system or site wide systems as deemed necessary.
- Lead implementation of actions identified in remediation plans.
- Working with other deparments during the gap analysis, action identification and implementation stage.
- Review of existing system qualification documentation in order to assess the overall level of compliance.
- Preparation, execution and/or approval of system qualification documentation.
- Generate system data process flow maps.
- Identification of system source data and meta data.
- Preparation, review and/or approval of system specific or site policies and procedures where required.
- Provide validation oversight on automation systems and support for the installation of new control systems on site.
- Proactively highlight issues around compliance.
- Perform periodic reviews of systems.
- Compliance with all site GMP and EHS policies and procedures.
- Min Level 8 Degree in ideally Computer Science, Engineering
- Minimum 3 years' experience of working in a Computer systems validation role in an FDA and HPRA approved site.
- Strong knowledge of Data Integrity, EU Annex 11, 21 CFR Part 11 and GAMP 5 requirements.
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.