A fantastic opportunity has arisen for a Site Process Microbiologist, Associate Director for our site in Biotech Dublin. The successful applicant will be responsible for overseeing and managing all microbiological aspects of the site's operations. This role requires a strong background in microbiology and experience in a regulated environment.
Bring energy, knowledge, innovation to carry out the following:
- Conduct Microbial Impact Assessments: Assess the potential impact of microbial contamination on the site's processes, products, and operations. Develop strategies to mitigate the risks associated with microbial contamination.
- Perform Quantitative Risk Assessments (QRAs): Apply statistical tools and risk assessment methodologies to evaluate the likelihood and severity of microbiological risks. Develop strategies to reduce these risks and ensure compliance with regulatory requirements.
- Act as a Subject Matter Expert (SME): Serve as the go-to person for all microbiological concerns and queries. Provide guidance and expertise to different departments within the organization regarding microbiological techniques, procedures, and best practices.
- Lead Investigations: Investigate microbial-related incidents, deviations, and non-conformances. Identify the root causes of microbial issues, develop corrective and preventive actions, and ensure their implementation to prevent recurrence.
- Conduct Equipment Reviews: Evaluate the effectiveness of equipment and systems used for microbial monitoring and control. Recommend improvements and upgrades to enhance the site's ability to prevent and detect microbial contamination.
What skills you will need:
To excel in this role, you will more than likely have:
- Bachelor's degree in microbiology or a relevant discipline is required. A master’s degree or above in microbiology or related field is preferable.
- Minimum of 7-10 years working experience in a similar role within a regulated environment, such as the pharmaceutical, food, or biotechnology industries.
- Expertise in Microbial Impact Assessments: Proven experience in performing microbial impact assessments, identifying potential risks, and implementing appropriate control measures.
- Knowledge of QRAs: Proficient in quantitative risk assessment methodologies as applied to microbiological risks. Able to analyse and interpret QRA results to inform decision-making and risk management strategies.
- Strong Investigative Skills: Skilled in leading investigations and root cause analysis related to microbial incidents and deviations. Experience in developing and implementing corrective and preventive actions.
- Equipment Review Experience: Familiarity with assessing the effectiveness of equipment and systems used for microbial monitoring and control. Knowledge of industry best practices and regulatory requirements.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please do not hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
