Cleaning Validation Specialist – Pharma (On-Site, Budapest)

Location: On-site (Budapest)
Employment Type: Contract or Fixed-Term
Start Date: Immediate
Language: Fluency in English required; Hungarian preferred

We are currently hiring a Cleaning Validation Specialist to join a leading pharmaceutical facility in Budapest. The ideal candidate will have deep expertise in cleaning validation strategy, protocol development, and compliance under cGMP for API or sterile manufacturing.

Key Responsibilities:

• Develop and review cleaning validation and verification protocols
• Maintain and calculate MACO and ARL limits
• Lead risk assessments (QRA) and contribute to validation master planning
• Execute/coordinate activities related to manual cleaning, CIP processes, and swab recovery studies
• Evaluate equipment trains, define worst-case products, and support contamination control strategies
• Monitor validation lifecycle: campaign length, clean/dirty hold times, visual inspections, and independent verification
• Support internal and external audits related to cleaning validation
• Ensure ongoing compliance with GMP, FDA, EMA, and ICH guidelines

Qualifications:

• Degree in Pharmaceutical Sciences, Chemistry, or related technical field
• Minimum 5 years of hands-on cleaning validation experience in a GMP-regulated environment (ideally API manufacturing)
• Strong familiarity with validation approaches: matrix/family grouping, bracketing, CPP/CQA analysis
• Experienced in documentation systems, audit preparation, and regulatory inspections
• Knowledge of best practices (e.g., Destin A. LeBlanc guidance) is a strong advantage