Qualification Engineer

About the job

Qualification Engineer: Qualification / Data Integrity / GMP / CSV / API Manufacturing / Drug Substance / Changes and Deviations / Qualification Project Plan / English / German

Background:

Pharma Engineering is looking for suitable candidates with experience both in equipment qualification in the area of Drug Substance (API manufacturing) as well as in Computer System Validation (CSV).

The working environment includes process equipment, media, utilities, air conditioning such as reactors, fermenters, centrifuges, purified water, steam, autoclaves, cleanrooms as well as the associated controls and process control systems (CSV).

The ideal candidate has experience in the qualification of production equipment as well as validation of computer systems and is familiar with the practical implementation of GMP guidelines. Changes and deviations are flawlessly documented and confidently presented together with equipment qualification or CSV during regulatory inspections.

Work and time management are self-organised and agreed upon amicably with the team and clients.

Tasks & Responsibilities:

• Creation of concepts, QPP (Qualification Project Plan) or VMP (Validation Master Plan)
• Preparation of qualification/validation plans and reports for all phases according to Roche Quality System
• Execution of qualifications/validations in all phases according to Roche Quality System
• Assessment of technical changes to equipment regarding their impact on the qualified state and independent handling of requalification activities
• GMP-compliant documentation of performed work and summary of deviations encountered
• Development of solutions for the deviations encountered
• Familiarisation with electronic qualification and validation software

Must Haves:

• Degree in a natural science or engineering field or relevant professional experience.
• 3 years of professional experience and solid experience in the qualification process
• Practical professional experience with qualifications/CSV of various types of equipment/systems and rooms/media
• Several years of experience in the GMP field with in-depth understanding of quality systems and lean implementation of GMP requirements
• Good knowledge of the topic "Data Integrity"
• Very good German language skills in spoken and written form, good English skills

Reference No.: 925156
Role: Qualification Engineer
Industry: Pharma
Location: Basel
Workload: 80 - 100%
Start: 01.10.2026 (Latest Start date 01.12.2026)
Duration: 12+ Months
Deadline: 27/09/2026

If this position has piqued your interest, please send us your complete CV. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your CV via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions, or our attractive payroll-only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.