CSV Engineer required to support our Validation Master Plan in Dungarvan Co Waterford
Consider joining Eurofins Lancaster Laboratories where people are the most important element in our business. Eurofins Lancaster Laboratories is a leading contract lab that provides testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide.
We have a fantastic opportunity for a CSV Engineer to join our team in Dungarvan Co Waterford
The primary purpose of this role is to lead computer system validation and equipment & instrumentation qualification activities, this person will be a key point of contact for Validation/Qualification activities on a day-to-day basis.
What will be involved?
- Prepare the laboratory Validation Master Plan with regard to computer systems, equipment and instrumentation.
- Be laboratory SME (Subject Matter Expert) on computer system validation and Data Integrity Requirement compliance
- Write and/or perform evaluations, reviews, risk assessments and testing for laboratory computerised systems considering the principles of GAMP5, namely, 21 CFR Part 11 EU Annex 11 and 15 along with Eurofins procedures
- Maintain up-to-date listing of all relevant systems and their GxP functionality
- Conduct GxP assessment for laboratory computer systems
- Conduct GAMP Risk Assessment for laboratory computer systems including management of requirements Trace matrix (RTM)
- Develop Validation Plans for laboratory computer systems validation projects
- Develop IQ, QQ, PQ protocols for the laboratory equipment, instrumentation and laboratory computerised systems
- Provide Technical review and approval (pre-approval) of Vendor supplied IQ, QQ protocols
- Conduct Electronic Record and Electronic Signature assessment for laboratory computer systems
- Provide Technical review and approval (Post-approval) of Vendor executed IQ, QQ protocols and complete equipment release statement ready for QA approval
- Develop Validation Summary Reports for laboratory computer systems validation projects
- Stay current with client, EU and US FDA validation expectations, regulations, and requirements; interpret regulations and coordinate implementation into internal practices
- Write and/or assist technical groups (equipment/Instrumentation SMEs) in writing User Requirement Specifications, change control and related documentation in accordance with established validation program
- Write and/or assist technical groups (equipment/Instrumentation SMEs) in writing Work Instructions, Standard Operating Procedures in accordance with Data Integrity Requirement compliance
- Implement quality systems and procedures in conjunction with management to direct the validation life cycle; maintain validation policies and operating procedures in a current compliant state.
- Review and approve documents ensuring GMP compliance, in-house procedure compliance completeness and consistency
- Deliver training to technical group to ensure full understanding of the company validation requirements with emphasis on the content of the validation master plan, validation template documents, internal procedures and management of validation changes.
- Experience with chromatography systems is also desirable.
What we are looking for?
- Bachelor’s degree in computer science, chemistry, biochemistry, microbiology or engineering
- At least 1 - 3 years’ experience in computer system validation support of pharmaceutical laboratory computer systems, equipment and instrumentation
- Executed GAMP5 projects in pharmaceutical laboratory environment
- Good team player, organised, accurate, have strong documentation skills
- Passionate about computer system validation and client service
- Good communication skills both internally and externally.
- The ideal candidate will be highly motivated, high achiever with strong project management skills to develop clear project plans and to complete projects within agreed timelines
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