Description
I am currently representing a Bio-tech company based in Sweden who is looking to fill a CSV engineer role for a 6-month contract.
This position uses policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems. Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
The ideal candidate should have the following experience and education:
- Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
- Experience in a GMP environment essential.
- Biologics experience highly desirable
- Management of CCs, CAPAs and other compliance related activities
- Delivers on daily tasks with a team of contractors
- Reports weekly to management on project progress
- Works with Global members to implement program improvement opportunities
- Become the SME for validation of these systems they manager
- Detailed knowledge of GAMP, 21CFR11 and Annex 11 required.
- Familiarity with MHRA, WHO and FDA/EMA guidelines for data integrity required.
- Knowledge of software development life cycle required.
- Experience with Software as a Service (SaaS), Infrastructure as a Service (IaaS) and/or Platform as a Service (PaaS) is desirable.
If this role is suited to either you or someone you know send an up to date CV to:
Regards
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