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,ISO 14698,ISO 11138,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,air samplingetc. İn pharmaceutical or medical device industries, sterilization process / validationand clenrrom validation/verificationexperience is an asset.
Ability to interpret updates to applicable international standards related with sterilization/microbiology& chemicaland 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 Validation/Qualification/Requalification Activities
Support Sterilization Validation/Qualification/Requalification activities
Support Laboratory Validation/Qualification/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.
Supporting the creation of laboratory microbiological (BB-LAL-environmental) and chemical (EO/ECH) test methods and programs
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.