Qualification- | Validation-Engineer

Pharmatronic AG was founded in 1985 and is part of the globally operating Glatt Group. We are a medium-sized Swiss engineering office and service company active in the fields of digitization & CSV, qualification, validation, calibration, automation/IT, MSRE, and engineering of pharmaceutical production and INFRA systems. Our customers are globally active companies in the fields of pharma, food, chemistry, medical technology, cosmetics, and healthcare.

You feel at home in the regulated environment, provide solution-oriented advice based on applicable regulations, and competently support customers. You enjoy interacting with people – whether in communication, exchanging ideas, or presenting tailored solutions. If you bring a service mentality and entrepreneurial thinking, you are exactly right at Pharmatronic!

Qualification- | Validation-Engineer

Your area of responsibility:

• Advising customers on qualification and GMP topics
• Leading and moderating meetings, solution-oriented handling of pain points
• Central contact person for QA, technical departments, and all project-involved parties
• Coordination and overview of all project activities in interdisciplinary teams
• Carrying out qualifications on pharmaceutical systems, ventilation systems,
• cleanrooms and equipment according to EU-GMP Annex 1 and Annex 15

Projects:

• Support in creating user requirement specifications (URS) and functional specifications (FS)
• Conducting risk analyses (FMEA)
• Creating qualification plans (QP) as well as SOPs, including adjustments
• Handling changes, deviations, and CAPA measures
• Creating qualification completion reports
• Creating test plans and qualification documents for DQ, IQ, OQ, and PQ phases

Qualification activities:

• Support in the validation of computerized systems (CSV)
• Conducting periodic reviews and supplier audits
• Performing DQ, IQ, OQ tests on pharmaceutical systems, infrastructure, and ventilation systems
• Performing site acceptance tests (SAT) as part of system qualification according to Annex 15

Additionally, you provide recommendations and optimization proposals to ensure GMP compliance.

Your applicant profile:

• Solid knowledge in qualification according to Annex 1, Annex 11, and Annex 15
• Experience with regulatory requirements: GxP, GAMP, FDA, EU guidelines; GAMP5
• Team-oriented working style, while being independent and responsible
• Careful work, high accuracy, and reliability
• Very good German skills and good English skills in spoken and written form
• Completed education as engineer, master, bachelor, or technician in electrical, process, or production engineering, packaging, or pharmaceutical technology

Our benefits:

• A responsible and interesting activity with a long-term perspective
• A corporate culture that values humanity, appreciation, and respect
• 40 hours/week with flexible and family-friendly working hours
• 5 weeks of vacation (6 weeks for over 50s)
• Modern and ergonomic workplace
• Various voluntary social events and an employee assistance program
• An open, motivated team looking forward to your collaboration
• A secure job in a renowned, globally operating, and growing family business

Are you looking for an environment where you can develop your skills, create real added value with a service spirit and entrepreneurial thinking, and actively contribute to the company's success?
Then we look forward to getting to know you.

Have we sparked your interest? Then do not hesitate!
We look forward to your online application.