Commissioning and Qualification Engineer

SII Group; Genf, Zürich; Remote; CHF 140,000 - 210,000; Full time

Job summary

SII Switzerland is seeking a Lead Commissioning & Qualification specialist to drive C&Q activities for pharmaceutical projects in the Geneva region. You will oversee qualification of facilities, utilities, OSD equipment, and CSV systems.

You will coordinate internal teams and contractors to deliver on time and within GMP requirements, prepare protocols, review reports, and support regulatory inspections. Strong project leadership and GMP experience are essential.

Qualifications

• Degree in engineering or a scientific discipline with pharma relevance.
• 5–10 years in the pharmaceutical industry, preferably in OSD.
• Strong C&Q expertise in GMP environments and CSV familiarity.

Responsibilities

• Lead C&Q activities for pharma projects.
• Oversee qualification of facilities, utilities, OSD equipment, and CSV.
• Coordinate internal teams and contractors to deliver on time, within budget, and GMP compliant.
• Prepare, review, and approve qualification and validation plans, protocols, and reports.
• Ensure compliance with GMP and FDA regulatory requirements.
• Manage investigations, change controls, and CAPA.
• Participate in internal audits and regulatory inspections as a technical expert.

Skills

C&Q expertise

GMP knowledge

Project management

CSV knowledge

Team leadership

Regulatory inspections

Education

Engineering degree

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.

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.