CSV Engineer - Divers and challenging project
- Employer
- NonStop Consulting
- Location
- Limerick
- Salary
- €50000 - €60000 per annum + Relocation Support
- Closing date
- Oct 20, 2018
View more
- Sector
- Pharmaceutical, Support Roles
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
- Jobseeker Type
- Professional
Job Details
The best employer in the Life Science Industry, voted as such on a regular basis, is looking for a CSV specialist that will help the company in some of the most exciting projects in the EMEA region.
Summary: The individual in this position implements policies and procedures to validate/qualify computer systems. Plans, coordinates, and participates in a compliant validation process for quality information technology systems which requires formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
* Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
* Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
* Lead process improvement projects to improve the validation of computerized systems
* Coordinates with other departments or outside contractors/vendors to complete validation tasks.
* Participates in regulatory audits and communicates company's computer validation policies.
* Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps and ensure best data integrity practices are enforced.
* Trains /advises less experienced Specialists and Technicians.
* Possesses a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211.
* Technical writing experience.
* Generation of Validation documents.
* Review and Approval of Validation documents.
* Strong attention to detail and accuracy.
* Experience in risk assessments in relation to validation activities.
* Advise and support all teams on computer validation activities.
Experience and Required Skills: Education and Experience:
Requires BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of related experience within the fields of computers and biotechnology; will substitute relevant experience for education. Experience with process control systems necessary.
Company
Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries.
Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery. Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.
The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors.
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