Cleaning Validation Manager

pOn 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. /pulliDevelop and maintain the site cleaning validation master plan, procedures and risk-based strategy (ICH Q9) /liliDefine product and equipment grouping, worst-case selection and scientifically justified acceptance criteria (HBEL/PDE, cleaning agents, microbiology) /liliPrepare, review and approve cleaning validation protocols and reports for manual and CIP cleaning /liliDefine sampling strategies (swab, rinse) and recovery studies in coordination with QC and analytical teams /liliAssess cleaning process parameters, difficult-to-clean locations and dirty/clean hold times /liliIntegrate cleaning into the contamination control strategy for sterile manufacturing (EU GMP Annex 1), together with Microbiology and Sterility Assurance /liliLead cleaning-related investigations, deviations, CAPA and change control, and determine revalidation needs /liliEnsure inspection readiness and support US FDA inspections and customer audits /liliProvide technical guidance, coordinate QA, QC, Manufacturing and Engineering, and train the teams involved /li /ulh3Desired profile /h3ulliDegree in Pharmacy, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology or Microbiology /lili7–10 years of experience in pharmaceutical manufacturing, validation or quality, including substantial hands‑on cleaning validation experience /lili3–5 years of experience leading validation projects or teams /liliExperience in sterile manufacturing strongly preferred /liliPractical experience with US FDA-regulated operations and FDA inspections highly desirable /liliStrong knowledge of cGMP, 21 CFR 210/211, EU GMP Annex 1, ICH Q9/Q10, relevant USP chapters and ALCOA+ data integrity /liliSolid understanding of residue limits (HBEL/PDE), sampling methods, analytical method suitability, CIP and manual cleaning /liliScientific rigor, sound judgment, excellent communication and stakeholder management skills /liliFluent English required; German or French is a plus /li /ulh3About Antaes /h3pFounded 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. /ppPresent in Switzerland, Singapore, and France, we support both Swiss and international clients in the following areas: /pulliOrganizational and transformation consulting /li /ulpBy joining our teams, you will discover: /pulliA dynamic team with a start-up mindset /liliPersonalized support and career development follow-up /liliOpportunities to expand your network through exciting challenges /liliEvents: team buildings, meet-ups, workshops, Summer Event /liliA company certified @HappyAtWork and committed to CSR, awarded Ecovadis Gold Medal 2025 /li /ulpYou too can be part of the Antaes adventure :) /ppWe sincerely appreciate the interest of all applicants in our organization. However, only those selected for further consideration will be contacted. /ppWhere applicable, the masculine form is used for readability purposes and is intended to be inclusive of all genders. /p #J-18808-Ljbffr