Senior Recruitment Consultant - Responsible for the Irish Life Science Sector
Company Profile:
Here at Hays we have a fantastic opportunity with our globally renowned biopharmaceutical client based in Dublin.
Our client is actively seeking an experienced CSV Engineer specialised in laboratory instrument qualification to join their team. The company has experienced rapid growth in recent years and currently boasts a large product portfolio across a variety of therapeutic fields such as immunology and oncology.
Job Descriptions:
The person will be responsible for ensuring that all laboratory instruments and computer systems are validated and qualified in compliance with regulatory requirements and industry standards.
Core Responsibilities:
* 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.
Essential Qualifications:
* 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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Project Management
Industries
Staffing and Recruiting
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