Commissioning and Qualification Engineer

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

• 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.
• 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.

• 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.
• 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.

At SII Switzerland, we stand out for our strong collaborative culture and recognized expertise in IT consulting and engineering services, supporting our clients in their digital transformation and innovation projects.

With a presence across three offices in Geneva, Lausanne, and Zurich, and a workforce of around 70 consultants, our teams contribute every day to creating a work environment that is stimulating and development-oriented, where expertise, teamwork, and initiative are valued.

For the third consecutive year, SII Switzerland has been certified Great Place To Work and ranked among the Best Workplaces in 'Suisse Romande', demonstrating our strong commitment to our employees and the quality of our practices.

True to our human-centered values, we are committed to supporting continuous learning and building strong relationships with our local ecosystem and partners.

Joining SII Switzerland means taking part in a collective adventure guided by our promise “Let’s Tech Together,” and helping to build a technological future that is innovative, sustainable, and responsible, at the heart of an environment that values autonomy, collaboration, and professional growth.

Who are we?

SII Group is an international provider of digital services, engineering, and technology consulting. Operating in 21 countries, we support our clients in their innovation and digital transformation projects.

Joining SII means becoming part of a collective adventure: Let’s Tech Together! This promise reflects our shared ambition: to build the technological future together, in an environment where experimentation and autonomy are encouraged, where innovation is at the heart of everything we do, and where every employee can achieve professional fulfilment and take ownership of their responsibilities within an enthusiastic and inclusive team.

Let’s Tech Together embodies who we are and who we aspire to be: a dynamic, innovative, and people-focused company. So, if these values resonate with you, join us!