MSAT Cleaning Validation Specialist

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

MSAT Cleaning Validation Specialist | GMP | Biopharmaceutical Manufacturing

KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.

We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life-changing products to patients.

We are seeking an experienced Cleaning Validation Specialist to join a leading biopharmaceutical manufacturing environment in a full-time, on-site role in Visp. We're seeking a technical expert with strong GMP knowledge and hands-on validation experience to play a key role in ensuring compliance, operational readiness, and inspection success. The contract is until 31st December with a possible extension.

You will provide technical expertise and operational support for all equipment cleaning validation activities, ensuring alignment with GMP requirements, regulatory expectations, and manufacturing excellence. This is an excellent opportunity to join a high-performing manufacturing environment where your expertise will directly contribute to compliance, quality, and operational success.

KEY RESPONSIBILITIES

• 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.

ESSENTIAL SKILLS AND EXPERIENCE

• Degree in Life Sciences, Biotechnology, Chemical Engineering, or related discipline.
• 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.
• Strong stakeholder management and cross-functional collaboration skills.
• Experience supporting customer or regulatory inspections.
• Structured, detail-oriented, with strong analytical and documentation skills.
• Fluent English required (German advantageous).

KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.

KPC – International is an Equal Opportunity Employer.