Senior Quality Engineer

GXP CONSULTING Switzerland; Basel; Hybrid; CHF 110,000 - 140,000; Full time

Job summary

GXP CONSULTING Switzerland is seeking a Senior Quality Engineer to support a client in a cGMP environment. You will drive qualification, validation and QA activities across equipment, systems, utilities and cleanrooms, ensuring ongoing GMP status and contributing to continuous improvement.

Responsibilities include preparing DQ/IQ/OQ/PQ documents, handling change control, deviations and CAPA, and facilitating inspections and audits with internal teams and external partners.

Qualifications

• Bachelor’s or Master’s degree in engineering, chemistry, pharmacy, process engineering or a related field.
• Minimum 5 years in a cGMP-regulated environment (pharma/biotech/medical devices).
• Strong hands-on QA with commissioning, qualification and validation experience.
• GMP knowledge and familiarity with international standards (FDA/EU GMP/ICH).
• Experience in cleaning validation and CSV is a plus.

Responsibilities

• Plan, coordinate, and execute qualification and validation activities for equipment and systems.
• Maintain GMP-compliant status and oversee re-qualification and re-validation efforts.
• Prepare, review, and execute DQ/IQ/OQ/PQ docs and validation strategies.
• Participate in change control, deviation and CAPA processes.
• Identify optimization opportunities and support implementation of improvements.
• Support regulatory inspections (FDA/EMA) and audits and maintain GMP documentation.

Skills

GMP knowledge

Quality Assurance

Validation

Documentation (DQ/IQ/OQ/PQ)

CAPA & deviation handling

Root cause analysis

German language

English language

Cross-functional collaboration

SAP familiarity

MasterControl familiarity

Education

Bachelor’s or Master’s degree in engineering, chemistry, pharmacy, process engineering

Tools

SAP

MasterControl

Job description

Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!

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.

Senior Quality Engineer (m/f/d)

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.

Key Responsibilities:

• Take responsibility for the planning, coordination, and execution of qualification and validation activities for equipment, systems, utilities, cleanrooms, 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, MasterControl, or comparable systems)
• Actively promote a strong quality, safety, and compliance culture across operations

Qualifications:

• 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 hand‑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
• Good level in German and English, both written and spoken (German required; English at C1 level or higher)

About us :

• Human-sized company with great colleagues from a large diversity of cultural and professional backgrounds
• We do care about our people, communicate openly and value feedback
• Work as a team where every member is valued and appreciated
• Opportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth.
• Continuous learning and development opportunities via internal or external training and workshops
• Competitive salary package in line with industry practice together with exceptional employment benefits

At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!