MS&T Scientist – Cleaning Validation
Galderma
Uppsala, Sweden
Job Description
As an MS&T Scientist – Cleaning Validation, you will provide technical expertise and operational support for cleaning validation activities across pharmaceutical manufacturing processes. Your role ensures that equipment cleaning procedures are scientifically justified, compliant with global regulatory standards, and effective in preventing cross-contamination. You will collaborate with MS&T process owners, QA, and Production to deliver robust validation strategies and maintain inspection readiness.
Key Responsibilities
- Develop and validate cleaning processes (manual, CIP/SIP) and analytical methods (TOC, HPLC, LC-MS);
- Author and execute cleaning validation protocols and reports;
- Perform risk assessments and establish acceptance criteria based on regulatory guidance;
- Ensure compliance with GMP, FDA, EMA, ICH, and PIC/S guidelines;
- Support regulatory submissions and health authority inspections;
- Collaborate cross-functionally with Development, Production, QA, QC, and Engineering;
- Drive continuous improvement initiatives to optimize cleaning procedures and reduce downtime.
Key Requirements & Qualifications
- MSc/PhD in Pharmaceutical Sciences, Chemistry, Biotechnology, or related field;
- 3–5 years of experience in pharmaceutical manufacturing or validation, with a focus on cleaning validation;
- Strong knowledge of GMP and cleaning validation principles;
- Excellent problem-solving, documentation, and communication skills;
- Ability to work independently and in cross-functional teams;
- Hands-on experience with injectable manufacturing processes is a plus;
- Lean or Six Sigma certification preferred.
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