Senior Pharmaceutical Commissioning & Qualification Engineer

SII Group Switzerland; Neuenburg; On-site; CHF 110,000 - 150,000; Full time

Job summary

SII Group Switzerland is seeking a Commissioning and Qualification Engineer to lead C&Q activities for pharmaceutical projects in Neuchâtel. You will oversee qualification of facilities, utilities, OSD manufacturing equipment and computerized systems (CSV), and coordinate internal teams and contractors to meet GMP standards.

Responsibilities include preparing qualification plans, ensuring regulatory compliance, and driving CAPA and change controls, while supporting internal audits and

Qualifications

• Degree in Engineering or a scientific discipline (Pharmaceutical Sciences, Mechanical Engineering, Chemistry, or equivalent).
• 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.
• Proven experience managing complex projects, teams, and external contractors.
• Knowledge of pharmaceutical equipment, utilities, automation systems, and Computerized System Validation (CSV).
• Experience in change management and regulatory inspection preparation.
• Excellent organizational, communication, and problem-solving skills.

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.

Skills

Commissioning

Qualification

Validation

Project management

Regulatory inspection preparation

Change management

Communication

Problem-solving

GMP knowledge

Leadership

Education

Engineering or scientific degree

Tools

CSV (Computerized System Validation)

Job description

SII Group Switzerland is seeking a Commissioning and Qualification Engineer to lead C&Q activities for pharmaceutical projects in Neuchâtel. You will oversee qualification of facilities, utilities, OSD manufacturing equipment and computerized systems (CSV), and coordinate internal teams and contractors to meet GMP standards.

Responsibilities include preparing qualification plans, ensuring regulatory compliance, and driving CAPA and change controls, while supporting internal audits and