Laboratory Equipment and Systems Validation Senior Specialist
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:
Your role will be defining of laboratory equipment and systems validation requirements, planning and reporting of laboratory equipment and systems validation activities and managing of validation standard operating procedures.
Your responsibilities:
- Deliver the quality assurance of Laboratory equipment and systems program consisting of entire system lifecycle (from URS, through implementation, changes, validation maintenance and periodical review to system retirement) in order to ensure compliance with relevant regulatory requirements and industry guidelines.
- Initiation, review and approval of TrackWise digital actions, deviation, change records, change controls and effectives checks.
- Maintenance of the SOP related to equipment and computerized systems validation.
- Review and approval of the Laboratory equipment and systems validation documentation.
- Participation in the meetings related to Validation activities.
- Participation in internal and external audits (Polish and Foreign Health authorities).
If you have:
- Higher directional education (Science, Engineering or related fields).
- Knowledge of GxP and Data Integrity principles.
- 3 - 5 years of experience in the Laboratory equipment and systems validation field.
- Experience in equipment, Computerized Systems, EMS validation.
- Experience in critical systems validation (HVAC, LAW water, WFI water etc.).
- Ability to recognize and solve problems independently, good organization and presentation skills, ability to work efficiently under time pressure.
- Experience in creation/maintenance and implementation of SOPs.
- Fluency in English.