Operations/Project Engineer Qualification

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 area 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 facilities: Cold rooms, cleanrooms, air conditioning/ventilation, compressed air, process air, WFI distribution, room monitoring, etc. The perfect candidate: has 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 is required. Further requirements include practical experience in the implementation of technical GMP specifications of the 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 matters in a target-group-oriented manner are essential for this position. Very good German and English skills are mandatory. Tasks & Responsibilities: Carrying out and supporting qualification activities in investment projects. Creating and executing qualification plans and reports Checking the evidence documentation for GMP compliance and fulfillment of acceptance criteria Creating, tracking, and closing qualification pending items Maintaining the inventory data of the qualified systems Partnership-based 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. Carrying out (re-)qualification measures from Changes and Deviations Planning and carrying out periodic qualification reviews Releasing technical planning documents Taking on inventory responsibility Must Haves: Completed training/degree in one of the following disciplines: Automation, mechanical engineering, process engineering, pharmaceutical technology, biotechnology Min. 5 years of 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, ability to work in a team and very good communication and coordination skills, also in 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 the 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 matters and convey them to customers or authorities in adapted language 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 Workload: 80-100% Working hours: Standard Start: ASAP- Duration: permanent Application deadline: Should this position have aroused 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 further 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. jpid84c113fjm jit0729jm jiy26jm