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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

Function
– 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.

Qualification
– 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
OrtMünchen
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