Operations/Project Engineer Qualification

Project overview

Operations/Project Engineer Qualification – Pharmaceutical Production / GMP / Qualification

Background: The Drug Product Qualification Department is looking for an expert in the field of qualification for independent operational engineering activities and project work in the Drug Product Basel and Kaiseraugst areas.

The production facilities consist of the following machines and equipment:

The perfect candidate: has completed training or a degree in fields such as automation, mechanical engineering, process engineering, pharmaceutical technology, or biotechnology. In addition, at least five years of professional experience in the qualification of automated pharmaceutical production facilities and sound knowledge in a GMP-regulated environment are required. Further requirements include practical experience in the implementation of technical GMP requirements from regulatory authorities (Swissmedic, FDA, EMA) in investment projects and operational engineering.

A structured, precise way of working, high social competence, and the ability to communicate complex issues in a target-group-oriented manner are essential for this position. Very good German and English skills are mandatory.

• Filling machines (Liquid/Solids), encapsulation, tableting, granulation, labeling machines, inspection machines, assembly line for syringe & autoinjector assembly, equipment washing machines, autoclaves, etc.
• Infrastructure facilities: cold rooms, clean rooms, HVAC, compressed air, process air, WFI distribution, room monitoring, etc.

Responsibilities

Must Haves:

Reference No.: 925086SBI

Role: Operations/Project Engineer Qualification (m/f/d)

Industry: Pharma

• Execution and support of qualification activities in investment projects.
• Creation and execution of qualification plans and reports
• Review of supporting documents for GMP compliance and fulfillment of acceptance criteria
• Create, track, and close qualification pending items
• Maintain inventory data of qualified equipment
• Collaborative work with interfaces
• Present qualification during inspections, answer inspection questions, maintain the contact person matrix.
• Estimate and evaluate the impact of changes and deviations on the qualified status and critical aspects.
• Execute (re)qualification measures arising from changes and deviations
• Plan and conduct periodic qualification reviews
• Approve technical planning documents
• Take over inventory responsibility
• Completed training/degree in one of the following fields: Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Technology, Biotechnology
• Min. 5 years of professional experience in qualification of automated pharmaceutical production (Drug Product)
• Professional experience in a GMP-regulated work environment
• Orderly, structured, and precise way of working
• High social competence, teamwork skills, and very good communication and coordination skills, including dealing with stakeholders at all levels
• Openness and ability to actively contribute in a flat, agile organization.
• Practical experience in implementing technical GMP requirements from regulatory authorities (Swissmedic, FDA, EMA) in investment projects and operational engineering
• Focus on delivering results that make a valuable contribution to the business
• Quick comprehension and ability to break down complex issues and communicate them in an adapted language to customers or authorities
• Independent and self-reliant handling of complex tasks as well as reliable enforcement of agreed priorities
• Very good German and English skills are required

Project details

Basel and Kaiseraugst

80-100%

Working Hours: Standard

ASAP-01.10.2026

permanent

Application Deadline: 21.07.2026

If this position has sparked your interest, please send us your complete dossier via the link in this advertisement. If this position does not quite fit your profile and you wish to receive other positions directly, you can also send us your dossier via this advertisement or to [contact removed].

Contact us for more information about our company, our positions, or our attractive payroll-only program: [contact removed].

• Start: 2026-10-01
• Location: Basel-Stadt, CH
• Languages: German

Source notes

ITech Consult is an ISO 9001:2015 certified Swiss company with branches in Germany and Ireland. ITech Consult specializes in placing IT candidates for contract work. We were founded in 1997 by IT professionals and therefore know how important professional support is for project search and work.