Senior Quality Engineer: GMP Validation & QA Lead

GXP CONSULTING Switzerland; Basel; On-site; CHF 120,000 - 160,000; Full time

Job summary

GXP CONSULTING Switzerland is seeking a Senior Quality Engineer (m/f/d) to join our Basel-area team. You will drive qualification, validation, and QA activities in a cGMP environment, ensuring ongoing GMP compliance and contributing to process improvements across systems and utilities.

You will collaborate with Engineering, Manufacturing, QA and external partners, mentoring junior staff and guiding regulatory readiness for inspections while maintaining documentation in SAP or MasterControl.

Qualifications

• Bachelor’s or Master’s degree in engineering, chemistry, pharmacy, or process engineering.
• At least 5 years in a cGMP-regulated environment (pharma/biotech/medical devices).
• Experience in Quality Assurance with commissioning, qualification, and validation.
• Strong knowledge of GMP and international regulatory standards (Switzerland, EU, USA).
• Experience in cleaning validation and/or CSV is a plus.
• Experience in deviations, root cause analysis and continuous improvement.
• Structured and autonomous with strong communication and teamwork.
• Proficient in German and English (German required; English at C1+).

Responsibilities

• Plan, coordinate, and execute qualification and validation activities for equipment, systems, and cleaning processes.
• Maintain GMP-compliant status of existing systems and oversee re-qualification and re-validation.
• Prepare, review, and execute DQ/IQ/OQ/PQ documents and validation strategies.
• Contribute to change control, deviations, and CAPA processes.
• Identify optimization opportunities and support implementation of improvements.
• Assist regulatory inspections and audits (FDA, EMA) and internal/external audits.
• Maintain GMP-relevant documentation (SOPs, risk assessments, logbooks).
• Serve as interface between Engineering, Manufacturing, QA and external partners.
• Provide guidance and mentoring to junior colleagues in validation and quality systems.
• Ensure proper documentation within electronic quality management systems (e.g., SAP, MasterControl).
• Promote a culture of quality, safety, and compliance across operations.

Skills

Quality Assurance

Commissioning

Validation

GMP knowledge

Root cause analysis

German language

English language

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 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
• 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!

If you also share the same passion and values, we will be glad to hear from you! Please send us your application.