Commissioning and 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

Who we are

SII Group is a trusted technology partner, SII provides high value added solutions for the IT projects of many large corporations. Since its founding in 1979, the Company has been providing solutions adapted to its clients’ needs, by relying on :

> Its acknowledged expertise in various industries and sectors

> Proven 'turnkey' solutions

> An efficient quality system

> Adaptable, evolving services

Today, with a staff of more than 18'000, SII Group is supporting companies across 20 countries.

At SII Switzerland we pay attention to the personal and professional wellbeing of our employees. We place our collaborators at the heart of our actions and activities. If you are motivated by the perspective of joining a big, trusted and recognized group, then let's meet !

Commissioning and Qualification Engineer.

Missions

• 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.

Profile

• 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.

For information

• Start date : ASAP
• Location : Neuchâtel - CH
• Duration : permanent contract
• Language : Fluent in English and French
• European citizen required