Senior Quality Engineer

About the role

GXP CONSULTING Switzerland is seeking an experienced Senior Quality Engineer to lead qualification, validation, and quality assurance activities within a cGMP‑regulated environment. You will ensure compliance across equipment, systems, utilities, cleanrooms and cleaning processes while driving continuous improvement.

Key responsibilities

• Plan, coordinate and execute qualification and validation for equipment, systems, utilities, cleanrooms and cleaning processes throughout their lifecycle.
• Maintain GMP‑compliant status of existing systems, including re‑qualification and re‑validation oversight.
• Prepare, review, approve and execute qualification documentation such as DQ, IQ, OQ, PQ and overall validation strategies.
• Participate in change control, deviation and CAPA processes related to qualification and validation.
• Analyze processes, identify optimisation opportunities and support implementation of improvements.
• Support regulatory inspections (FDA, EMA) and internal/external audits.
• Maintain GMP‑relevant documentation including SOPs, risk assessments and logbooks.
• Act as a key interface between Engineering, Manufacturing, QA and external partners.
• Provide technical guidance and mentoring to junior colleagues.
• Ensure proper documentation in electronic quality management systems (e.g., SAP, MasterControl).

Required profile

• Bachelor’s or Master’s degree in engineering, chemistry, pharmacy, process engineering or a related scientific discipline.
• Minimum 5 years of experience in a cGMP‑regulated environment (pharmaceutical, biotech or medical device).
• Hands‑on experience in quality assurance with a focus on commissioning, qualification and validation.
• Strong knowledge of GMP requirements and international regulatory standards (Switzerland, EU, USA, FDA, ICH).
• Experience with cleaning validation and/or computer system validation (CSV) is a strong advantage.

Required skills

• Qualification and validation methodologies (DQ, IQ, OQ, PQ).
• Good Manufacturing Practice (GMP) compliance.
• Cleaning validation.
• Computer System Validation (CSV).
• Electronic quality management systems (e.g., SAP, MasterControl).
• Change control, deviation handling and CAPA processes.