Scientific Microbiologist Specialist
hace 4 días
At Bayer, we are redefining the way we work to achieve higher productivity and faster innovation. Our approach is centered around Dynamic Shared Ownership (DSO), a revolutionary concept that aims to drive better results. Learn more about DSO and its impact on your new role here https://www.bayer.com/en/strategy/strategy.
Key Responsibilities:
- Develop, transfer, and implement testing methods for starting materials, device components, packaging materials, and drug products in accordance with approved and validated test methods.
- Support validation and implement testing of environmental monitoring samples, bioburden, monitoring, and analysis, including water, compressed air, endotoxin tests, and others as needed.
- Responsible for supporting the development of local SOPs and other documents.
- Oversee daily microbiology laboratory operations and supervise team members, including the possibility of regency.
- Ensure the reliability of daily analyses and results, data integrity, OOS and CAPA analysis, and root cause investigation.
- Assist with calibration and maintenance programs for microbiology laboratory equipment.
- Prepare laboratory metrics.
- Train laboratory technicians on laboratory procedures.
- Monitor progress and escalate issues to the Microbiology Supervisor if necessary.
- Capable of managing laboratory teams and substituting for the supervisor in case of absence.
Requirements:
- Bachelor's degree in Microbiology or Biotechnology (Mandatory).
- At least 1 year of experience in microbiological laboratories.
- Desirable: at least 1 year of experience in industrial test or test validations.
- Advanced English proficiency.
- Ability to create documents, validation protocols, and other related activities.
- Knowledge of validation of analytical methods.
- Familiarity with QMS systems and subsystems.
- Process Validation Knowledge.
- Understanding of laboratory systems and systems management.
- Knowledge of environmental monitoring sampling and testing, including but not limited to water, air, surfaces, and others.
- Knowledge of critical systems monitoring, including but not limited to endotoxin tests, sterility tests, and others related.
- Knowledge of pharmaceutical and medical devices culture methods.
- Knowledge of microbiological identification methods.
- Proficient with Microsoft Office tools.
- Demonstrated advanced problem-solving abilities.
- Knowledge of current Good Manufacturing Practices (cGMP).
- Desirable: knowledge of ISO systems (9001, 13485, 14644, 17025).
- Able to communicate verbally and in writing at a level commensurate with regulatory and technical reporting requirements.
- Ability to multitask in a fast-paced work environment and self-direct, as required.
- Ability to manage technical information and reports.
- Ability to adapt to changing priorities and work in a team environment.
What We Offer:
- Competitive salary.
- Attractive benefits package.
- Range of development opportunities.
- Good working conditions and comfortable working environment.
At Bayer, we value diversity, equity, and inclusion. We aim to create an inclusive environment where everyone can feel authentic, respected, and valued equally. Every day, we strive to reflect our values through our people's unique capabilities, experiences, and aspirations. We intentionally seek diversity to enable our people to bring their fullest potential out and encourage others to do so. Our company thrives when we leverage our capabilities to lead cultural transformation in our business, positively impacting society.
Candidates meeting the requirements based on the job profile will be considered for employment without any disadvantages due to physical disability, race, color, religion, sex, age, sexual orientation, or gender identity.
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