Operations/Project Engineer Qualification

Operations/Project Engineer Qualification - Pharma Production / GMP / Qualification Background: The Department Drug Product Qualification is looking for an expert in the field of qualification for independent operations engineering activities or project work in the field of Drug Product Basel and Kaiseraugst. The production facilities consist of the following machines and systems: • Filling machines (Liquid/Solids), encapsulation, tableting, granulation, labeling machines, inspection machines, assembly line for assembly of syringes & autoinjectors, equipment washing machines, autoclaves, etc. • Infrastructure systems: Cold rooms, clean rooms, air conditioning/ventilation, compressed air, process air, WFI distribution, room monitoring, etc. The perfect candidate: possesses completed training or a degree in disciplines 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 plants as well as sound knowledge in the GMP-regulated environment are required. Further requirements include practical experience in implementing technical GMP specifications of regulatory authorities (Swissmedic, FDA, EMA) in investment projects and in operations engineering. A structured, exact way of working as well as high social competence and the ability to communicate complex issues in a manner appropriate to the target group are essential for this position. Very good German and English skills are mandatory. Tasks & Responsibilities: • Implementation and support of qualification activities in investment projects. • Creation and execution of qualification plans and reports • Checking the evidence documents for GMP compliance and fulfillment of acceptance criteria • Creating, tracking, and closing qualification pending items • Maintaining the inventory data of the qualified plants • Collaborative cooperation with interfaces • Presenting the qualification during inspections, answering inspection questions, maintaining the contact partner matrix. • Estimating and evaluating the impact of changes and deviations on the qualified status and critical aspects. • Executing (re-)qualification measures from changes and deviations • Planning and conducting periodic qualification reviews • Approving technical planning documents • Taking on inventory responsibility Must Haves: • Completed training/degree in one of the disciplines: Automation, Mechanical Engineering, Process Engineering, Pharmaceutical Technology, • Min. 5 years professional experience in qualifications of automated pharma production (Drug Product) • Professional experience in a GMP regulated work environment • Orderly, structured, and exact way of working • High social competence, teamwork skills, and very good communication and coordination skills, including when dealing with stakeholders at all levels • Openness and ability to actively contribute in a flat, agile organization. • Practical experience in the implementation of technical GMP requirements of regulatory authorities (Swissmedic, FDA, EMA) in investment projects and operations engineering • Focus on delivering results that make a valuable contribution to the business • Quick comprehension as well as the ability to break down complex issues and convey them in appropriate language to customers or authorities • Independent and autonomous processing of complex tasks as well as reliable enforcement of agreed priorities • Very good German and English skills are required Reference Nr.: 925086SBI Role: Operations/Project Engineer Qualification (m/f/d) Industry: Pharma Work location: Basel and Kaiseraugst Percentage: 80-100% Working hours: Standard Start: ASAP-01.10.2026 Duration: permanent Application deadline: 21.07.2026 If this position has piqued 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: +41 41 760 77 01. About us: ITech Consult is an ISO 9001:2015 certified Swiss 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.