GMP Cleaning Validation Lead – Biopharma

KPC International; Oberwallis; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

KPC International is seeking an experienced Cleaning Validation Specialist to join a biopharmaceutical manufacturing environment in Visp, on-site. This role focuses on ensuring GMP-compliant cleaning validation across COP, CIP, USP, DSP, and buffer/media systems, with collaboration across R&D, Manufacturing, QC, and QA.

The ideal candidate holds a life sciences or related degree and has hands-on validation experience, strong regulatory knowledge (FDA/EMA), and proven ability to support

Qualifikationen

• Proven GMP cleaning validation experience within pharmaceutical or biopharmaceutical manufacturing.
• Hands-on experience with equipment cleaning validation (COP, CIP, USP, DSP, buffer/media systems).
• Strong understanding of FDA / EMA regulations for cleaning validation and contamination control.
• Experience writing and reviewing validation protocols, reports, and GMP SOPs.
• Fluent English required (German advantageous).

Aufgaben

• Lead and execute equipment cleaning validation activities, including protocol and report authoring for COP, CIP, USP, DSP, and buffer/media preparation systems.
• Support validation execution, including parts washer COP validation.
• Manage the full SOP lifecycle related to cleaning validation (authoring, review, updates, approvals).
• Collaborate with R&D, Manufacturing, QC, and QA on new or modified cleaning processes.
• Ensure validated cleaning methods are effectively implemented into routine manufacturing operations.
• Act as technical lead within cross-functional cleaning validation projects.
• Assess deviations, change controls, and technical change requests (DRs, CRs, TCRs).
• Support customer and regulatory inspections, including preparation and presentation of validation data.
• Evaluate customer requests related to cleaning validation topics.
• Maintain oversight and consistency across all cleaning validation activities.

Kenntnisse

GMP cleaning validation

COP validation

CIP validation

USP validation

DSP validation

Regulatory inspections

Documentation

Stakeholder management

Cross-functional collaboration

Analytical skills

Ausbildung

Bachelor's degree in Life Sciences / Biotech / Chem Eng

Jobbeschreibung

KPC International is seeking an experienced Cleaning Validation Specialist to join a biopharmaceutical manufacturing environment in Visp, on-site. This role focuses on ensuring GMP-compliant cleaning validation across COP, CIP, USP, DSP, and buffer/media systems, with collaboration across R&D, Manufacturing, QC, and QA.

The ideal candidate holds a life sciences or related degree and has hands-on validation experience, strong regulatory knowledge (FDA/EMA), and proven ability to support