Cleaning Validation Expert
1 week ago
Cleaning Validation Engineer
We are seeking a highly motivated and experienced Cleaning Validation Expert to join our organization in a leading Biopharmaceutical setting. This is an exciting opportunity for individuals who want to work with a multinational company known for its excellence in the industry.
Key responsibilities include designing, authoring, reviewing, approving, and executing qualification and validation documentation as well as cycle development studies. The ideal candidate will have 2+ years of experience working in cleaning validation in a fill-finish environment.
- Develop and implement qualification and validation plans for equipment and processes.
- Design and execute change controls to ensure compliance with regulatory requirements.
- Resolve technical issues during study execution and engage with production, maintenance, and quality teams.
- Collaborate with cross-functional teams to drive continuous improvement through Lean Six Sigma methodologies.
- Ensure compliance with global policies, procedures, and guidelines, as well as regulatory requirements.
Responsibilities:
- Bachelor's degree in Applied Pharmaceutical/Biological/Chemical sciences or a related field.
- 2+ years of experience in cleaning validation in a fill-finish environment.
- Experience with process monitoring systems, automation systems, and operational intelligence data systems.
- Knowledge of sterile fill-finish processes and equipment.
This role offers a dynamic work environment and opportunities for growth and development.
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