Senior C&Q Engineer - GMP/CSV for OSD Pharma

Groupe Sii; Neuenburg; On-site; CHF 120,000 - 180,000; Full time

Job summary

SII Switzerland is seeking a Lead Commissioning & Qualification (C&Q) expert for pharmaceutical projects. You will oversee qualification of facilities, utilities, OSD manufacturing equipment, and CSV systems, coordinating internal teams and contractors to meet GMP requirements.

In this role, you will prepare and review qualification plans, ensure regulatory compliance (GMP, FDA), and drive CAPA processes. A strong background in GMP environments and cross-functional leadership is essential.

Qualifications

• 5–10 years of experience in the pharmaceutical industry, ideally in Oral Solid Dosage (OSD) manufacturing.
• Strong expertise in Commissioning, Qualification & Validation (C&Q) within a GMP environment.

Responsibilities

• Lead Commissioning & Qualification (C&Q) activities for pharmaceutical projects.
• Oversee the qualification of facilities, utilities, OSD manufacturing equipment, and computerized systems (CSV).
• Coordinate internal teams and contractors to ensure projects are delivered on time, within budget, and in compliance with GMP requirements.
• Prepare, review, and approve qualification and validation plans, protocols, and reports.
• Ensure compliance with internal procedures and regulatory requirements (GMP, FDA).
• Manage investigations, Change Controls, and Corrective and Preventive Actions (CAPA).
• Participate in internal audits and regulatory inspections as a technical expert.

Job description

SII Switzerland is seeking a Lead Commissioning & Qualification (C&Q) expert for pharmaceutical projects. You will oversee qualification of facilities, utilities, OSD manufacturing equipment, and CSV systems, coordinating internal teams and contractors to meet GMP requirements.

In this role, you will prepare and review qualification plans, ensure regulatory compliance (GMP, FDA), and drive CAPA processes. A strong background in GMP environments and cross-functional leadership is essential.