We are urgently seeking an experienced Validation Consultant to lead validation efforts for our aseptic filling lines, ensuring all processes meet regulatory standards.

Key Responsibilities:

• Validate aseptic filling lines in compliance with GMP, FDA, and EMA regulations.
• Develop and execute IQ/OQ/PQ protocols for filling line equipment.
• Analyze validation data, troubleshoot, and create validation reports.
• Perform risk assessments and address compliance gaps.
• Collaborate with cross-functional teams including QA, Engineering, and Production.

Qualifications:

• Degree in Engineering, Biotechnology, or related field.
• 5+ years of validation experience in pharmaceutical/biotech environments.
• Strong knowledge of GMP, FDA, and EMA regulations.
• Proven experience with aseptic filling lines and IQ/OQ/PQ protocols.
• Strong analytical, problem-solving, and communication skills.

Preferred:

• Experience with automation and biologics/vaccine production.

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

Greg King