Microbiologist

A CDMO partner of RBW are expanding their team and looking for an experienced Microbiologist to join them in Colorado!

With vast industry experience, previously focused on Dermatology products, this organisation are looking to develop their offering into Injectables. Creating a unique opportunity for a Microbiologist to build out their Sterility lab.

This position will be largely independent and you will be responsible for developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications as they relate to sterility assurance. This is an exciting opportunity to forge your own path in Sterility Assurance and create a necessary department of the business to be successful.

Responsibilities

• Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate.
• Provide technical support for all sterility assurance programs (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
• Participate or provide guidance for sterility assurance programs during internal and external audits, including regulatory inspections, as needed
• Perform or provide guidance for sterility testing
• Apply problem solving and quality improvement tools and techniques, including, nonconformance, deviation, preventative and corrective actions and how to overcome barriers to quality improvements
• Participate in continuous improvement projects to improve quality performance at the site
• Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends
• Create, execute, and/or evaluate change controls related to sterility assurance programs
• Create, execute, review, and/or approve technical documents related to sterility assurance programs
• Lead or support risk assessments related to sterility assurance programs
• Lead or provide technical support for root cause investigations related to sterility assurance programs
• Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level
• Authoring and maintenance of procedure, policy, and form updates within quality system
• Evaluation of procedures for compliance and alignment to industry standards
• Trains, mentors, and develops less experienced colleagues within Sterility Assurance

Requirements

• Knowledge of pharmaceutical, food and cosmetic, and clinical microbiology in order to interpret the impact and relative importance of microorganisms when they are isolated from raw materials, component, finished product, water bioburden, equipment and environmental monitoring samples.
• Demonstrated technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting
• Skill in problem solving.
• Ability to manage multiple projects concurrently and under tight time constraints.
• Ability to clearly communicate (verbal & written) and work well with employees at all levels.
• Ability to be organized and self-directed.
• Ability to use specialized computer software such as spreadsheets and graphing software.
• Mechanical/electrical ability to effect minor instrument repairs is preferred.
• Advanced skills in math-related processes, with an emphasis on statistics.
• Ability to fluently and clearly write lab notebooks, reports, and regulatory submissions.

If you could be interested in applying, I would love to hear your thoughts and discuss the finer details with you. Please apply to this advert or reach me directly.