Commissioning & Qualification Engineer (Oral Solid Dosage) – available at short notice – 100% on-site Pharma Industry (Ref. 2820) - 6 months temporary contract - E/F

AurigaVision AG; Neuenburg; On-site; CHF 100,000 - 140,000; Full time

Job summary

AurigaVision AG in the Neuchâtel area is seeking an experienced Commissioning & Qualification Engineer (Oral Solid Dosage) for a 6-month, on-site assignment. You will lead commissioning and qualification activities for facilities, utilities, equipment, automation, and computerized systems, coordinating with engineering, QA, suppliers, and contractors.

The ideal candidate holds an engineering degree and 3–5 years in pharma GMP, with proven C&Q project management, audits experience, and fluent

Qualifications

• Engineering degree or equivalent in a technical/scientific field.
• 3–5 years of pharmaceutical industry experience, especially in oral solid dosage validation within GMP.
• Experience managing complex commissioning & qualification projects and coordinating contractors.
• Strong knowledge of equipment, utilities, automation, computerized system validation, and qualification requirements.
• Experience with project management, change management, investigations, and product lifecycle activities.
• Involvement in health authority inspections, including prep, presentations, documentation, and audit responses.
• Excellent English and French language skills.

Responsibilities

• Oversee commissioning and qualification activities for capital projects, ensuring completion within timelines and budgets.
• Lead and coordinate internal and external teams responsible for qualifying facilities, utilities, oral solid dosage equipment, and computerized systems.
• Develop C&Q strategies, plans, schedules, acceptance criteria, protocols, and final reports.
• Coordinate execution, review, approval, and completion of qualification deliverables per milestones.
• Collaborate with internal departments, suppliers, engineering partners, construction teams, and validation contractors to meet project objectives.
• Support investigations, change controls, impact assessments, and corrective action plans related to commissioning and qualification.
• Act as SME during internal and external audits and provide required qualification and validation documentation.

Skills

English

French

Project management

Quality/regulatory knowledge

GMP awareness

Education

Engineering degree

Relevant scientific/technical discipline

Job description

Our client is a leading pharmaceutical company with a state-of-the-art production site in the Neuchâtel area, operating globally and ranking among the largest employers in the industry in Switzerland. To support capital projects within a GMP-regulated manufacturing environment, we are looking for an experienced professional as

Commissioning & Qualification Engineer (Oral Solid Dosage) – French & English speaking – available at short notice – 100% on-site Pharma Industry (Ref. 2820) - 6 months temporary contract – Neuchâtel Area

In this project-focused role, you will lead and coordinate commissioning and qualification activities for facilities, utilities, manufacturing equipment, automation, and computerized systems. You will work closely with Engineering, Technical Services, Manufacturing Science and Technology, Quality Assurance, end users, suppliers, and external contractors to ensure successful project delivery. The position combines technical leadership, contractor coordination, project scheduling, and hands-on qualification expertise

• Oversee commissioning and qualification activities for capital projects, ensuring completion within agreed timelines and budgets.
• Lead and coordinate colleagues and external contractors responsible for qualifying facilities, utilities, oral solid dosage equipment, and computerized systems.
• Develop C&Q strategies, plans, schedules, acceptance criteria, protocols, and final reports.
• Coordinate the execution, review, approval, and completion of qualification deliverables according to project milestones.
• Collaborate with internal departments, suppliers, engineering partners, construction teams, and validation contractors to achieve project objectives.
• Support investigations, change controls, impact assessments, and corrective action plans related to commissioning and qualification activities.
• Act as a subject-matter expert during internal and external audits and provide the required qualification and validation documentation

Your profile

• Degree in Engineering, Life Sciences, Mechanical Engineering, Chemical Engineering, or another relevant technical or scientific discipline.
• Approximately 3-5 years of relevant experience in the pharmaceutical industry, involving oral solid dosage validation in a GMP environment.
• Proven experience managing complex C&Q projects, external contractors, project resources, and multidisciplinary teams.
• Strong knowledge of equipment, utilities, automation, computerized system validation, and pharmaceutical qualification requirements.
• Experience with project management, change management, investigations, and product lifecycle activities.
• Previous involvement in health authority inspections, including preparation, presentations, documentation, and responses to audit questions.
• Excellent English and French skills are required.

Full discretion is guaranteed and we will gladly answer any additional questions.