What will you do?
- Establish and maintain MS&T organizational capability and governance processes to
- Lead validation and ensure execution of Validation Master Plans and continuous data monitoring/trending
- Keep technology strategies to current and future standards in partnership with key functions (Production, Development, QA/Regulatory, Business)
- Execute product remediation of technical issues and provide technical support
- Product Stewardship: full accountability and oversight of product related technical process and quality aspects to ensure manufacturing of robust products (Lifecycle Management of a production process)
- Technical Stewardship: Oversight and definition of processes and standards to maintain existing technologies and implement new innovative technologies for manufacturing including the development of requirements for new equipment vTechnical Transfer Leadership: Lead technical transfers of products within and between sites as well as from development into large scale facilities
- Process Support Leadership: Ensure end-to-end oversight of process performance and early initiation of corrective actions based on monitoring of product/process parameters. Ensure current process technical issues are solved in a timely manner, drive implementation of CAPAs etc.
- Validation Leadership: Own and write VMP. Provide governance for site validation activities. Perform scientific evaluation/risk assessments of APR/PQR, CPP/CQA, CPV
What do we expect?
- 5-8 years of experience in manufacturing/manufacturing science or technology/technical development
- Thorough understanding of manufacturing processes (Up- & Downstream) and related process equipment
- 2-5 years of experience in executing process validation, having led and managed validation projects
- Expert in reviewing and writing technical reports
- Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions)
- Strong in leadership and people management, with ability to build up and develop the team
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
- Fluent in English, willing to learn Polish language
- Flexible and adaptable