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The Computer Systems Validation Senior Specialist will plan, manage, and implement the validation of Biotech equipment Computer Systems. He will act as the validation owner for the group of systems they are selected for. The candidate will work with the user and the Engineer to define and execute the program of work to deliver a fast track validation program.
Management and delivery of validation implementation will be a major part of the scope. The role will be a full-time contract role based in Polpharma Biologics Warsaw with occasional travel to Gdansk in the course of duties.
- Assisting with the development of system requirements and specifications to ensure that the requirements are testable and that the relevant regulatory requirements are met
- Evaluating proposed changes to validated water systems and recommend the level of validation activities required
- Identify and qualify all systems which impact cGMP operations using a risk-based methodology
- Ensure initiation/preparation and closeout of all deviations, discrepancies and change control documents related to water systems
- Presentations for Polish and Foreign Health authorities, therefore an ability to present and be articulate are required
- University degree in a scientific or engineering discipline with a strong preference for those with project start up experience on medium to larger projects
- 5+ years of experience within the pharmaceutical industry
- A proven track record experience in the implementation, upgrade or remediation project of production Computer Control Systems
- Experience and expertise in entire validation lifecycle (from URS to PQ) of production Computer Systems being used in biotech or other GMP environment
- Project management experience with production/building/enterprise (SAP etc.) Computer Systems to allow the adequate management of the project
- Experience in production Engineering, QC, Quality or production is considered important to understand how the systems will be used by the user
- High standard of documentation literacy and GDP/Data integrity to ensure the high standard of output in GMP/GDP environment
- Deep understanding of relevant regulatory requirements, preferably demonstrated through participation in specialist courses delivered by SMEs
- Fluency in written and spoken English and working experience with the language
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Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.