Validation Engineer 100% CDD – OM Pharma – Meyrin, GE

In order to strengthen our validation team in current projects and routine activities, we are looking for our Validation Engineer for a period of 18 months. In this position, you will work in our Product & Industrial Development department (P&ID) and will be responsible for managing the validations of manufacturing and cleaning processes at our biotech production site in Meyrin. Your responsibilities are as follows:

  • Contribute to establish strategies for process and cleaning validations and continuous cleaning and process verification

  • Execute validation activities according to planning: process and cleaning validation in the frame of site projects, Continuous Cleaning and Process Verification, DHT/CHT validations, manufacturing holding times, validation of manual cleaning processes etc…

  • Manage and coordinate the corresponding operational activities in close collaboration with Manufacturing, QA, P&ID teams and QC laboratories

  • As Project Member act as Validation SME/interface for projects of the site: attend to project team meetings and contribute to projects (validation strategies, planning, execution, etc.)

  • Write and review validation protocols, raw data, reports and SOP’s of the unit in compliance with GMP

  • Define, monitor, implement and close CAPA and change control (risk analysis, action plan, action owner …) in collaboration with the various departments involved.

  • Manage deviations issued as part of validation activities

  • Lead risk analyses in close collaboration with Manufacturing, QA, QC and P&ID teams

  • Answer to questions in the field of process and cleaning validations from other departments such as Manufacturing, QA, RA-CMC, QC

  • Provide all relevant data to fulfill validation parts of regulatory files

We are looking for a dynamic, motivated and flexible person with the following profile:

  • University degree in the scientific field (MSc, engineer)

  • Several years of experience in a similar position in a pharmaceutical industry

  • A first experience in the microbiological field (an asset)

  • Knowledge of GMP guidelines (GXP, ICH, Ph. Eur. …).

  • Very good level in French both written and spoken and very good writing skills in English.

You are a rigorous person, autonomous and you like working in a multitasking way. With an entrepreneurial spirit, you like to take a step back to analyze situations. You You define yourself as a solution-oriented person who is a driving force for innovation. Thanks to your communication skills and strong team spirit, you integrate quickly into a new environment and easily establish collaborative links with other departments.

Vifor Pharma Group, formerly Galenica Group, is a global pharmaceutical company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions.The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma. With its unique expertise in the field of immunology, OM Pharma develops and manufactures infectious diseases/OTX products for respiratory tract infections, lower urinary tract infections, ear care, abdominal distension, chronic obstructive pulmonary disease, chronic venous insufficiency, diabetic retinopathy, haemorrhoids, menometrorrhagia (heavy menstrual bleeding).

Location: Switzerland – Meyrin/Geneva

Function: Technical Operations

Company: OM Pharma

Seniority Level: Specialist

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+41 58 851 81 24

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