Senior Quality Engineer

GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle.

To support our client and ensure consistently high levels of quality and compliance, we are looking for an experienced Senior Quality Engineer
. In this role, you will take on a key responsibility for qualification, validation, and quality assurance activities within a cGMP-regulated environment and actively contribute to the continuous improvement of processes, systems, and teams.

• Take responsibility for the planning, coordination, and execution of qualification and validation activities for equipment, systems, utilities, clean rooms, and cleaning processes across the entire lifecycle
• Ensure the ongoing GMP-compliant status of existing systems, including planning and oversight of re-qualification and re-validation activities
• Prepare, review, approve, and execute qualification and validation documentation such as DQ, IQ, OQ, PQ
  , as well as overarching validation strategies
• Participate in change control, deviation, and CAPA processes related to qualification and validation activities
• Analyze existing processes,
  identify optimization opportunities
  , and actively support the implementation of improvement measures
• Support the preparation, execution, and follow-up of regulatory inspections (e.g., FDA, EMA) as well as internal and external audits
• Prepare, review, and maintain additional GMP-relevant documentation (e.g., SOPs, risk assessments, logbooks)
• Actively contribute to cross-functional and project teams, serving as a key interface between Engineering, Manufacturing, QA, and external partners
• Provide technical guidance and mentoring to junior colleagues in validation and quality system activities
• Ensure proper documentation within electronic quality management systems (e.g., SAP, Master Control, or comparable systems)
• Actively promote a strong quality, safety, and compliance culture across operations

• Bachelor’s or Master’s degree in engineering, chemistry, pharmacy, process engineering
  , or a comparable scientific or technical discipline
• At least 5 years of professional experience in a cGMP-regulated environment (pharmaceutical, biotech, or medical device industries)
• Several years of hands‑on experience in Quality Assurance
  , with a strong focus on commissioning, qualification, and validation
• Very good knowledge of GMP requirements and international regulatory standards (Switzerland, EU, USA; FDA, EU GMP, ICH)
• Specific experience in cleaning validation and/or Computer System Validation (CSV) is a strong advantage
• Experience in managing deviations,
  root cause analysis
  , and continuous improvement initiatives
• Structured, reliable, and precise working style with a high level of autonomy and accountability
• Solution-oriented, resilient, and communicative personality with a strong quality and customer-focused mindset
• Fluent in German and English
  , both written and spoken (German required; English at C1 level or higher)