Senior Cleaning Validation Lead – Sterile Pharma (Zurich)

Antaes Consulting; Zürich; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

Dynamic culture

Career development support

Networking events

CSR recognition

Zusammenfassung

Antaes Consulting seeks a Cleaning Validation Manager for its Canton of Zurich on-site pharma site. Lead cleaning validation and evaluation for sterile manufacturing, develop master plans and risk-based strategies in line with ICH Q9 and regulatory expectations.

Manage sampling strategies, investigations, CAPA and revalidations, and support US FDA inspections. The role requires 7–10 years in pharma manufacturing/validation, 3–5 years leading projects or teams, and strong cGMP knowledge; English

Qualifikationen

• Must have strong knowledge of cGMP, 21 CFR 210/211, EU GMP Annex 1, ICH Q9/Q10, USP chapters and ALCOA+ data integrity.
• Extensive knowledge of residue limits (HBEL/PDE), sampling methods, analytical method suitability, CIP and manual cleaning.
• Fluent English; German or French a plus.

Aufgaben

• Lead the cleaning validation and cleaning evaluation program for the Swiss manufacturing site (100% workload).
• Develop and maintain the site cleaning validation master plan, procedures and risk-based strategy (ICH Q9).
• Define product and equipment groupings, worst-case criteria, and 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 and analytics teams.
• Assess cleaning process parameters, difficult locations and hold times.
• Integrate cleaning into contamination control for sterile manufacturing with Microbiology and Sterility Assurance.
• Lead cleaning-related investigations, deviations, CAPA and change control; determine revalidation needs.
• Support US FDA inspections and customer audits; ensure inspection readiness.

Kenntnisse

Strong knowledge of cGMP and quality

Excellent communication andStakeholder

Fluent English (plus German/French)

Ausbildung

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

Jobbeschreibung

Antaes Consulting seeks a Cleaning Validation Manager for its Canton of Zurich on-site pharma site. Lead cleaning validation and evaluation for sterile manufacturing, develop master plans and risk-based strategies in line with ICH Q9 and regulatory expectations.

Manage sampling strategies, investigations, CAPA and revalidations, and support US FDA inspections. The role requires 7–10 years in pharma manufacturing/validation, 3–5 years leading projects or teams, and strong cGMP knowledge; English