Microbiology Specialist

GETINGE GROUP

Ever since Maquet's founding in Germany in 1838, it has helped hospitals with innovative products such as the first motorized operating table. A Maquet table was used for the first heart transplant surgery in 1967, in South Africa. Firsthand understanding of clinical challenges and continuous optimization of its products established Maquet as a leading provider of medical systems.  

Today Maquet is a product brand within Getinge. The Maquet brand provides a broad range of products and innovative treatment solutions and infrastructure functions for extremely demanding hospital departments, including operating rooms, hybrid operating rooms, catheter laboratories and intensive care units as well as intra- and inter-hospital patient transportation. 

The production is conducted at facilities in Brazil, Dominican Republic, France, Canada, China, Germany, Poland, Sweden, Turkey, the UK and the US. In total, Getinge has over 12.000 employees in more than 41 countries. Getinge's head office is located in Gothenburg, Sweden.

Qualifications:

• B.S,M.S,Ph.D degree in biology, biochemistry, microbiology, Biomedical or a related field
• Preferably A minimum of 3 years total work experience in healthcare/ biotech/ medical devices/ pharmaceutical industry
• Knowledge of tools/ methodologies such as investigation methods, process validation, statistical process control (SPC), protocol/ report preparation.
• Knowledge of ISO 13485, ISO 11135, ISO 11737-1, AAMI/ANSI ST72, ISO 14644, USP, EP and FDA requirements
• Good knowledge of MS Office applications is required and SAP is an asset
• Good command of English is compulsory, German knowledge would be an asset
• Exceptional analytical, problem solving & root-cause analysis skills
• Excellent communication skills, ability to work in a team environment and lead a project team
• Ability to lead or work with multi- departmental project teams and resolve quality related issues in a timely and effective manner
• Strong interpersonal skills and problem solving ability
• High level of attention to details, timeliness and accuracy
• Be self-motivated, self-starter, be able to meet deadlines, be a good team player
• No military obligation for male candidates
• Ability to work with external partners is required.
• Technical drawing interpretation 

• Experience in microbiological testing like bioburden, bacterial endotoxin, particle testing, etc. İn pharmaceutical or medical device industries, sterilization process / validation experience is an asset.

• Ability to interpret updates to applicable international  standards related with sterilization/microbiology and guidelines and implements these changes into the quality system 

• Ability to solve process issues, perform root cause analyses, and implement process improvements

Job Description: 

• Responsible for technical analytical test method development, validation, routine microbiological analytical test method validations, requalification activities related to medical devices and combination products.
• Responsible to review environmental monitoring data for cleanroom
• Responsible to review Cleanroom Requalification Activities
• Support Sterilization Validation and Requalification activities
• Applying Scientific/GMP theories, principles & techniques to solve problems.
• Contributes in trouble shooting/impact assessment for atypical conditions during routine testing/validations.
• Review product and process change control documentation and specifications
• Coordination of analytical test method validation/qualification and requalification activities with third part laboratories and Laboratory operation team
• Overview routine laboratory process
• Developing, validating and requalifying laboratory processes, test methods for new and existing medical devices and combination products.
• Responsible for providing scientific support and ensuring quality compliance in accordance with documented procedures for all aspects of functional responsibility
• Interprets updates to applicable international  standards related with sterilization and guidelines and implements them into the quality system
• Reviewing and evaluating process issues, performing root cause analyses, and implementing process improvements.
• Record, analyze and interpret data
• Remain up to date with scientific and research developments
• Collaborating with team members and overseeing external partners (contact sterilizers, testing labs, etc) to achieve project objectives.