LSC have a great contract opportunity for a CSV Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have previous industrial experience in a similar role and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
We are seeking a highly skilled and experienced Computer System Validation (CSV) Engineer with a strong background in Laboratory Instrument Qualification. The ideal candidate will be responsible for ensuring that all laboratory instruments and computer systems are validated and qualified in compliance with regulatory requirements and industry standards.
- Develop and execute validation plans, protocols (IQ/OQ/PQ), and reports for laboratory instruments and computer systems.
- Perform risk assessments and impact analyses to determine the validation requirements for new and existing systems.
- Ensure compliance with regulatory requirements (e.g., FDA, EMA, GxP) and industry standards (e.g., GAMP 5).
- Collaborate with cross-functional teams, including Quality Assurance, IT, and Laboratory Operations, to ensure successful validation and qualification activities.
- Maintain and update validation documentation, including validation master plans, standard operating procedures (SOPs), and validation summary reports.
- Conduct periodic reviews and requalification of laboratory instruments and computer systems to ensure continued compliance.
- Provide training and support to laboratory personnel on validation and qualification processes.
- Investigate and resolve validation-related issues and deviations.
- Stay current with industry trends and regulatory changes to ensure ongoing compliance and continuous improvement.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
- Minimum of 5 years of experience in computer system validation and laboratory instrument qualification.
- Strong knowledge of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) and industry standards (e.g., GAMP 5).
- Experience with validation of laboratory instruments such as plate readers, liquid handlers, spectrophotometers, and other analytical equipment.
- Excellent documentation and technical writing skills.
- Strong analytical and problem-solving abilities.
- Ability to work independently and as part of a team.
- Excellent communication and interpersonal skills
Apply via this advert or contact Paul O'Driscoll on 021 4777 329 if you have any more questions about this opportunity!
