Laboratory Analyst

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:

·         Bachelor's Degree required or equivalent level in Microbiology, Biology, Biotechnology with a minimum of three years in-depth experience in working as a microbiologist in the microbiology, hygiene and cleanliness at a manufacturer (medical devices or pharmaceuticals)

·         Must be familiar with Bioburden test ,Bacterial Endotoxin Test,Environmental Monitoring tests,water tests and test method validation; knowledge of aseptic processing highly desired

·         Requires strong problem solving and analytical skills

·         Skills for regulation interpretation and implementation

·         Able to give hygiene related trainings

·         Being familiar with GMP&GLP requirements , quality systems specifically ISO 13485, ISO 14644, ISO11737 regulations and laboratory equipments / instruments is an asset

·         Fluency in English (Speaking / Reading / Writing)

·         Good knowledge of problem solving tools (knowledge of 6 Sigma tools is a plus)

·         Computer proficiency using word processors, spreadsheet, graphical, and statistical software programs is required.

·         Must be able to handle multiple tasks/projects and manage priorities accordingly

·         Be able to meet deadlines

·         Be self motivated & able to work independently

·         Good communication skills

·         Teamwork oriented,

·         Ability to work in a fast-paced environment overtime and in a shift.

·         Military service must be completed for male candidates

Job Description:

·         Responsible for all  specialized testing including Bacterial Endotoxin testing; bioburden testing for Raw Material, semi-finish, and finish product samples and routine monitoring/validation studies for water systems.

·         Performing related protocols by applying microbiological knowledge and concepts.Coordinate testing od qualification, requalification and revalidation activities (bioburden, sterility, etc.).

·          Prepares documentation of validation efforts using sound scientific principles 

·         Identify basic testing approaches to perform microbiological testing, investigations, isolation and identification according to guidance standards

·         Perform various microbiological tests for personal care products such as total plate count, yeast and mold count, enrichment, etc.

·         Perform various microbiological tests for medical devices such as Endotoxin Assay, and Bioburden Test, etc.

·         Perform various microbiological tests for water type samples such as  Escherichia coli.

·          Develop protocols, reports, and methods in collaboration with inter-departmental teams

·         Set parameters of complex laboratory machines applying microbiology knowledge and concepts to perform environmental control testing, process control, and final product release testing.

·          Participate in process improvement projects and propose recommendations for manager approval

·         Create, develop and perform validation plans/reports for laboratory equipment and methods,

·         Investigate and perform lab related  corrective and preventative actions (CAPA) testing and non-conformity (NC)’s

·         Daily reporting activities.