Qualification & Validation Engineer (m/f/d)
Pharmatronic AG
Schweiz - Pratteln
Key information
- Publication date:08 May 2024
- Workload:100%
- Contract type:Unlimited employment
- Place of work:Schweiz - Pratteln
Job summary
Join Pharmatronic AG, a leading Swiss engineering firm, since 1985. Enjoy a supportive work environment with growth opportunities.
Tasks
- Oversee qualification tasks in interdisciplinary teams.
- Conduct qualifications for pharmaceutical systems and equipment.
- Serve as the main contact for QA and project stakeholders.
Skills
- Engineering degree in relevant fields required.
- Knowledge of GxP, GAMP, and FDA regulations essential.
- Fluent in German and good English communication skills.
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Your area of responsibility:
- You keep track of the tasks to be performed and act confidently in interdisciplinary teams
- You carry out qualifications on pharmaceutical systems, ventilation systems, clean rooms, and equipment
- You act as the central contact person for QA, technology, and all other parties involved in the project
- You have direct contact with the customer and advise them on qualification
- You partially lead meetings and address pain points in a solution-oriented manner
- You assist in the creation of specifications (URS) and requirements documents (FS)
- You conduct risk analyses according to FMEA
- You create qualification plans (QP) for DQ, IQ, OQ, and PQ phases as well as qualification final reports
- You create SOPs and adapt them
- You handle changes & deviations, as well as CAPAs
- You conduct DQ, IQ, and OQ tests for pharmaceutical systems and infrastructure, especially ventilation systems according to Annex 1 with execution of SAT
- You assist in the validation of computer-based systems (if needed)
- You conduct periodic reviews and supplier audits
- You make recommendations and optimization proposals to ensure GMP compliance
Our requirements:
- You have completed training as an engineer, master's, bachelor's, or technician in the field of electrical, process, or chemical engineering, packaging, or pharmaceutical technology
- You have knowledge of Annex 1, Annex 11, and Annex 15 (the knowledge can of course vary for the various annexes)
- You have good experience with regulations: GxP, GAMP, FDA, and EU guidelines
- You are team-oriented and reliable
- You work independently, carefully, and accurately
- Very good German and good English skills in spoken and written form complete your profile
Our benefits:
- A responsible and interesting activity with a long-term perspective
- A secure workplace in a renowned, globally operating, and steadily growing family business
- A corporate culture that places the individual person at the center alongside customers, where appreciation and respect are lived
- Furthermore, we offer you a 40h/week (flexible and family-friendly working hours) with 5 weeks of vacation (6 weeks for over 50), various voluntary company social events, an Employee Assistance Program, a modern and ergonomically designed workplace, and a team that looks forward to you
