Engineer Qualification & Validation
ITech Consult AG
- Employment type
- Full-time
- Location
- Rotkreuz
- Company
- ITech Consult AG, 6343 Rotkreuz
- First posted
Engineer Qualification & Validation
Engineer Qualification & Validation - GMP / Validation / Pharma / Plants
Background: You don't just want to manage documentation, but with your know-how, directly contribute to the stability, compliance, and further development of our production? Then this role is for you. In our team, we are responsible for the qualification and validation of our manufacturing equipment. This makes us an important partner for routine production and for improvements to existing plants and processes. For our location in Rotkreuz, we are looking for a personality who likes to take responsibility, works close to production, and pragmatically advances technical and compliance-related topics.
The perfect candidate: The perfect candidate has a completed degree in natural or engineering sciences and two to three years of solid professional experience in qualification and validation in the regulated pharmaceutical or medical technology field. Additionally, they are characterized by a structured, independent way of working, strong communication skills in German and English, and the competence to accompany complex production projects and audits in a sovereign manner.
Tasks & Responsibilities:
You plan and coordinate qualifications of small equipment up to complex production plants.
You create and moderate risk analyses and derive suitable measures from them.
You support process and method validations as well as requalifications and revalidations in the event of changes.
You actively work on improvement projects in our existing production.
You analyze disturbances, deviations, and technical issues in the production environment together with specialist departments.
You assess, together with internal partners, when there is a need for qualification or validation.
You coordinate independently with various stakeholders and keep topics reliably moving.
You support audits technically and represent your area of responsibility in a sovereign manner.
You ensure that regulatory requirements and internal quality standards are met.
Must Haves:
A completed degree in natural sciences, engineering sciences, or a comparable field
2-3 years of experience in a regulated environment, for example in pharma, diagnostics, medical technology, or a similar industry
Practical experience in the qualification of equipment or plants
Knowledge of process and method validation is a plus
Experience with quality-relevant documentation and risk analyses
Technical understanding and interest in production-related topics
A structured, independent, and proactive way of working
Enjoyment of collaboration in interdisciplinary teams
Very good German language skills and good English language skills
Reference Nr.: 925071SBI
Role: Engineer Qualification & Validation
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Working hours: Standard (hybrid model)
Start: ASAP
Duration: unlimited
Application deadline:
If this position has sparked your interest, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile so well and you wish to receive other positions directly, you can also send us your dossier via this advertisement or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions, or our attractive payroll-only program: .
About us:
ITech Consult is an ISO 9001:2015 certified company with branches in Germany and Ireland. ITech Consult specializes in the placement of IT candidates for contract work. We were founded in 1997 by IT professionals and therefore know how important professional support is when searching for and working on projects. jpiddf05b28jm jit0728jm jiy26jm
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Posted 2 days ago