Cleaning Validation Manager

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

On behalf of one of our clients, a manufacturer of sterile pharmaceutical products for the US market, we are looking for a Cleaning Validation Manager to lead the cleaning validation and cleaning evaluation program of its Swiss manufacturing site.

• Develop and maintain the site cleaning validation master plan, procedures and risk-based strategy (ICH Q9)
• Define product and equipment grouping, worst-case selection and scientifically justified 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 in coordination with QC and analytical teams
• Assess cleaning process parameters, difficult-to-clean locations and dirty/clean hold times
• Integrate cleaning into the contamination control strategy for sterile manufacturing (EU GMP Annex 1), together with Microbiology and Sterility Assurance
• Lead cleaning-related investigations, deviations, CAPA and change control, and determine revalidation needs
• Ensure inspection readiness and support US FDA inspections and customer audits
• Provide technical guidance, coordinate QA, QC, Manufacturing and Engineering, and train the teams involved

Desired profile

• Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology or Microbiology
• 7–10 years of experience in pharmaceutical manufacturing, validation or quality, including substantial hands‑on cleaning validation experience
• 3–5 years of experience leading validation projects or teams
• Experience in sterile manufacturing strongly preferred
• Practical experience with US FDA-regulated operations and FDA inspections highly desirable
• Strong knowledge of cGMP, 21 CFR 210/211, EU GMP Annex 1, ICH Q9/Q10, relevant USP chapters and ALCOA+ data integrity
• Solid understanding of residue limits (HBEL/PDE), sampling methods, analytical method suitability, CIP and manual cleaning
• Scientific rigor, sound judgment, excellent communication and stakeholder management skills
• Fluent English required; German or French is a plus

About Antaes

Founded in 2007, Antaes is a Swiss management and technology consulting firm ranked among the top 10 consulting companies in Switzerland. We have over 300 experienced engineers who share our passion.

Present in Switzerland, Singapore, and France, we support both Swiss and international clients in the following areas:

• Organizational and transformation consulting

By joining our teams, you will discover:

• A dynamic team with a start-up mindset
• Personalized support and career development follow-up
• Opportunities to expand your network through exciting challenges
• Events: team buildings, meet-ups, workshops, Summer Event
• A company certified @HappyAtWork and committed to CSR, awarded Ecovadis Gold Medal 2025

You too can be part of the Antaes adventure :)

We sincerely appreciate the interest of all applicants in our organization. However, only those selected for further consideration will be contacted.

Where applicable, the masculine form is used for readability purposes and is intended to be inclusive of all genders.