Validation Team Manager
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:
Managing the Validation Team. Provide expertise in biotechnology process validation, cleaning validation, transport validation, continuous process verification and related activities. The Validation Manager will oversee the execution of processes validation, cleaning validation and transport validation ensuring efficient, timely validation, and registration of new processes.
Your responsibilities:
- Managing a Validation Team by organizing the work of the subordinate team to make the most effective use of working time and task execution, monitoring the status of ordered tasks
- Representing the company of development pre-validation / validation strategy, including the strategy for supportive studies
- Supervision and monitoring of activities between all departments involved in individual activities of drug substance manufacturing process validation, cleaning validation and transport validation
- Initiation of the monitoring and continuous process verification phase and compilation of the first APQR
- Contribution to the overall strategy and plans of TT projects scope of which includes the process validation phase, including the creation of schedules and budgets
- Supervision and/or development of validation plans, scientifically sound technical strategies (with validation team), contingency plans, identify obstacles and propose possible solutions.
- Assessment and planning of resource needs (full time, investment, external costs), strategies and schedules
- Forming and leading a validation team, setting team priorities and meetings, coordinating team activities, ensuring compliance with EHS and GMP guidelines
- Supervision of updating documentation and / or project tracking tools as planned
- Supervision and/or development of the main validation documentation (e.g.: protocol, report). Support the production of the master batch report and documents related to the validation of the DS manufacturing process
- Review and coordinate the delivery of input data to key documents and registrations for accuracy and completeness
- Participation in preparations for and in the inspections of pharmaceutical regulatory authorities
- Coordinating the preparations for the production campaign (as part of the validation of the active substance manufacturing process)
- Participation in the development and updating of procedures and documentation templates as part of validation of manufacturing processes, cleaning validation and transport validation
- Contribute to the optimization of validation processes
- Providing validation knowledge
If you have:
- Higher education in the field: biotechnology, pharmacy or related
- 5 years of professional experience in the biotechnology industry in the production area and process validation, cleaning validation and transport validation
- Several years of experience in managing a team
- Experience in working with recombinant proteins on a production scale
- Practical knowledge of process validation (for biotechnological products), cleaning validation and transport validation
- Excellent knowledge of GMP, EMA and FDA requirements and current guidelines for process /cleaning /transport validation in the biotechnological industry,
- Experience in keeping process and project documentation
- Fluent English, both writing and speaking
- Ability to identify and solve problems independently
- Very good knowledge of MS Office and MS Project