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Ingenieur, Process Validation Manager
Bayern, München, PLZ 8
Posted 1 Monat ago

BANDAO recruits for Bausch + Lomb. Bausch + Lomb, a division of Bausch Health, is one of the best-known and most respected health care brands worldwide. Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. Approximately 21,000 employees are united around Bausch + Lomb’s mission of improving people’s lives with health care products. Bausch + Lomb manufactures and markets health care products directly or indirectly in approximately 100 countries.

BANDAO recruits for the refractive surgery division – Technolas Perfect Vision – in Munich a:

Process Validation Manager (all gender) – Ophthalmology – Consumables and Devices

– Analyzing the production process of consumables and devices for use in ophthalmology, including process-requirement specification and validation for each production stage (Internal and External).
– Manage the Process Validation Master Plan during Equipment Qualification and Process Validation for new and existing products and processes.
– Manage the Process during Equipment Re-Qualification and Process Re-Validation for new and existing Products and Processes.
– Validation of QMS software for production that affects product compliance.
– Coordination of the release into the final production process after equipment qualification, QMS software validation and process validation was successful completed.
– Push all project tasks independently by collecting required information for managing all production process relevant validation task and required technical documentation activities according to internal standards.
– Coordination planning and of equipment qualification and record.
– Release of qualified equipment into the production process.
– Maintain the list of all released validated processes and update if required.
– Planning, Initiation and Recording the data for regular monitoring for all validated production processes.
– Train SME for process validation and equipment qualification.
– Assessment and evaluation of the urgency of problems within the validated process environment. Highlighting top priorities to management.

– Technical or Scientific University Degree
– At least 5 years of professional experience in the field of medical products, especially sterile disposable products.
– Solid experience and state-of-the-art knowledge of the Design Control Process for Medical Devices according to MDR and MDSAP requirements
– Experience in product and process validation of sterile disposable products for worldwide registration
– Expertise in the following standards is advantageous:
– ISO 13485 / 21 CFR 820
– ISO 11137: Sterilization of health care products
– ISO 11607: Packaging for terminally sterilized medical devices
– ISO 10993: Qualification of Biocompatibility
– Very good English skills, both written and spoken
– Practice-oriented and autonomous working method

You are a highly committed and responsible person with structured and team oriented workstyle? You want to work in a motivating and international environment using latest technologies and tools? You want to apply agile processes in a regulated industry?

Then please send us your up to date CV (no motivation letter needed), your salary expectation and your earliest possibly entry date by email.

Job Features

Job CategoryMedizintechnik
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