Cleaning Validation Lead – Sterile Pharma (ICH/Q9)

Antaes Consulting; Zürich; On-site; CHF 140,000 - 190,000; Full time

Benefits offered by this job

Dynamic team with start-up mindset

Career development support

Team events and CSR initiatives

HappyAtWork certification

Job summary

Antaes is seeking a Cleaning Validation Manager to lead the cleaning validation program at its Swiss manufacturing site for sterile pharmaceutical products destined for the US market.

You will develop the master plan, define HBEL/PDE criteria, coordinate sampling strategies, and drive validation reports while ensuring compliance with EU GMP Annex 1 and ICH Q9/Q10. Fluency in English is required; German/French is a plus.

Qualifications

• Fluent English required; German or French a plus.
• 7–10 years of pharma manufacturing, validation or quality experience.
• 3–5 years leading validation projects or teams.
• Experience in sterile manufacturing preferred.
• Practical experience with US FDA-regulated operations and FDA inspections desirable.
• Solid knowledge of cGMP, 21 CFR 210/211, EU GMP Annex 1, ICH Q9/Q10, USP; data integrity (ALCOA+)

Responsibilities

• Develop and maintain the site cleaning validation master plan, procedures and risk-based strategy (ICH Q9).
• Define product and equipment grouping, worst-case acceptance criteria (HBEL/PDE, cleaning agents, microbiology).
• Prepare, review and approve cleaning validation protocols and reports for manual and CIP cleaning.
• Define sampling strategies (swab, rinse) and recovery studies with QC/analytical teams.
• Assess cleaning process parameters, difficult-to-clean locations and hold times.
• Integrate cleaning into contamination control strategy for sterile manufacturing (EU GMP Annex 1).
• Lead cleaning-related investigations, deviations, CAPA and change control; determine revalidation needs.
• Ensure inspection readiness and support FDA inspections and customer audits.
• Provide technical guidance, coordinate QA/QC/Manufacturing/Engineering and train teams involved.

Skills

English fluency

German or French (bonus)

Stakeholder management

Strong communication

Analytical thinking

Project leadership

Education

Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology or Microbiology

Job description

Antaes is seeking a Cleaning Validation Manager to lead the cleaning validation program at its Swiss manufacturing site for sterile pharmaceutical products destined for the US market.

You will develop the master plan, define HBEL/PDE criteria, coordinate sampling strategies, and drive validation reports while ensuring compliance with EU GMP Annex 1 and ICH Q9/Q10. Fluency in English is required; German/French is a plus.