Computer Systems Validation Senior Specialist (Clean Utility Systems, Water Systems)
Duchnice
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your role:
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.
Your responsibilities:
- 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
If you have:
- 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