Senior Engineer CQV (m/f/d)

About the role

Join Exyte as a Senior Engineer CQV to lead qualification and validation projects for pharmaceutical production equipment. You will work in a dynamic environment, ensuring compliance with GMP standards and driving project success.

Key responsibilities

• Prepare qualification and validation plans, specifications, risk analyses, and design documents.
• Plan and execute DQ, IQ, OQ, and PQ activities for production equipment.
• Prepare qualification reports and review supplier documentation.
• Document work in a GMP‑compliant manner, handle change control and deviations, and maintain SOPs.
• Lead a small project team, manage project timelines, budgets, and resources.
• Mentor junior engineers and independently execute work packages.

Required profile

• Degree in engineering, natural sciences, or a pharmaceutical‑related field.
• Several years of professional experience in the pharmaceutical industry.
• Strong knowledge of GMP regulations and industry standards.
• Willingness to travel within Switzerland.
• Very good German and good English language skills.

Required skills

• Qualification and validation planning.
• DQ, IQ, OQ, PQ execution.
• GMP‑compliant documentation.
• Change control and deviation management.
• Standard Operating Procedure (SOP) development.