What are the responsibilities and job description for the Senior Microbiologist position at Actalent?
Top Skills' Details:
Microbiology
Environmental Monitoring
Sterility Testing
Aseptic Technique
CAPA
Description:
Develop validation protocols to fulfill international standards, industry, and corporate requirements.
Collaborate with manufacturing engineering and facilities to ensure the installation, operation, and maintenance of controlled environmental systems.
Develop and perform validations of cleanroom and controlled areas, including performing testing for validation and ongoing monitoring, and reviewing the data monthly to identify trends.
Develop and perform validations of the water purification system and the compressed air system, including performing testing for validation and ongoing monitoring, and reviewing the data monthly to identify trends.
Develop and perform validations of gamma sterilization, including performing quarterly dose audits, bioburden monitoring, and annually reviewing the sterilization families for changes.
Develop and perform validations of post-manufacturing cleaning, including performing testing for validation and ongoing monitoring, and reviewing the data monthly to identify trends.
Assess the performance of validations against international standards and internal procedures for end user sterilization, end user cleaning, biocompatibility, and manufacturing part detergent cleaning.
Coordinate and execute accelerated and real time aging studies.
Coordinate and execute biocompatibility studies in the support of new products.
Investigate and document laboratory out of specification non-conformances and CAPA.
Coordinate microbiology testing and analysis of particle size, HEPA airflow, endotoxins, and microbial growth, biocompatibility endpoints, etc.
Prepare and conduct training sessions for the quality, R&D, and manufacturing personnel to ensure conformance to international and internal standards, aseptic cleanroom standards, sterilization standards, cleaning standards, etc.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of Competence
Strong analytical / problem solving skills.
Strong interpersonal, influence and communication skills (written/verbal/presentation) at multiple levels and across boundaries; appropriately shares viewpoint and encourages the free exchange of information and opinions.
Strong working knowledge of ISO and AAMI standards, and US FDA and EU regulations pertaining to microbiological control, industrial sterilization, and biological safety.
Demonstrated experience in the validation, operation, and monitoring of water and compressed air purification systems including the development of testing protocols, performance of testing for validation and routine monitoring, and analysis of data to identify trends.
Demonstrated experience in the operation of microbiological laboratory equipment, including autoclaves, air samplers, particle counters, bacterial endotoxin testers, total organic carbon testers, incubators, and contact plate sampling and analysis.
Demonstrated experience in the validation of equipment and microbiological test methods, including the development of protocols, work instructions, and reports.
Demonstrated experience in the investigation and corrective action of microbiological out of specification reports and corrective and preventive action reports.
Demonstrated experience in the validation of industrial sterilization methods, including gamma sterilization; including the performance of quarterly dose audits, bioburden monitoring, and analysis of changes.
Demonstrated expertise in the use of computer software for the performance of microbiological monitoring and trending, such as Microsoft Office (Word, Excel, Access, PowerPoint, Visio).
Knowledge of the performance of cleaning validation of medical devices.
Knowledge of the performance of biological safety assessments for the biocompatibility of medical devices.
Additional Skills & Qualifications:
Bachelor of Science in Microbiology or Biology (Master’s Degree is preferred)
6-8 years of work experience as an industrial biologist in medical device or biologics industry, or an equivalent combination of education and experience.
Other degree programs with microbiology course work may be considered if candidates also possess 7-9 years of relevant industrial microbiology and/or sterility assurance work experience.
Work Environment:
This person will be an individual contributor and will be considered a leadership role. This is a 1st shift role Monday-Friday. This is a business causal environment.
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $62 - $63
