The Microbiology Manager reports to the Director of Environmental Monitoring/Sterility Assurance and is responsible for the implementation of policies to ensure programs, processes, and testing is in place for monitoring of the environment for product cleanliness. This includes coordination of safety and compliance for multiple buildings and or sites, including hosting inspections by regulatory agencies at all levels. Evaluate safety protocols and organize safety training companywide. The ideal candidate will have experience in medical device and or pharmaceutical manufacturing, with specific knowledge of Chemicals, Solutions, Biological Buffers, Media and or like products. Reliable transportation and a flexible schedule are a mustDUTIES AND RESPONSIBILITIES
- Leads the Microbiology Program, which includes focus on Environmental Monitoring including but not limited to controlled areas, classified cleanrooms (i.e. ISO 7, and or 5), air, water, viable and non-viable testing processes, to assure compliance in relation to requirements applicable to internal procedures, and regulatory agency inspections.
- Knowledge of bacteriological, serological, mycological, parasitological, and other microbiological principles.
- Familiar with Methods and or Assays used in the laboratory for detection and identification of Contamination or Microbes
- Knowledge of chemical principles and techniques used in the examination of surface, water and air contaminates.
- Proper PPE laboratory safety precautions and procedures, including the ability to create and implement procedures
- Knowledge of methods of transmissions and causes of contamination, and control of contamination
- Ability to perform a variety of laboratory tests and examinations with applicable equipment.
- Ability to keep records and prepare clear and concise written reports on examinations performed.
- Establish and maintain effective working relations with Internal/External customers.
- Ability to effectively manage small number of direct reports.
- Follows and or helps create Safety Material Data Sheet (SDS) for incoming, and outgoing products.
- Overseas all viable and or non-viable are monitoring and testing
- Coordinates testing of all water ports, including trouble shooting failures to completion, with corrective actions.
- Recommends systems for Micro Testing, including lab equipment, and or PPE required.
- Follows-up on corrective actions. Ensures proper coordination of internal and external initiated inspections and or audits and manages regulatory facility inspections in relation to the micro department.
- Assures placement of monitoring plates are effective, and mapped out to exact locations for results that represent actual environmental risks.
- Develops and implements micro testing policies and procedures, and a schedule of routine testing (i.e. Bioburden, and or Endotoxin, or other EM related testing)
- Monitors compliance with external regulations, and or internal, customer procedures as applicable.
- Drafts reports to document findings, and trends data to provide for Management Review
- Participates in improving Laboratory Safety
- Support and collaborate with the Safety Team in relation to Labs and inspections throughout the company
- Performs other related duties as assigned.
- Manages documentation, reporting, and closure of compliance issues.
KNOWLEDGE / SKILLS / EXPERIENCE
- Bachelors degree in Microbiology (additional education in related field such as Chemical Engineering preferred but not required)
- Three years of experience in related industry (with 1 year in management/supervision) preferred
- Functional working knowledge of equipment related to EM.
- ISO 13485:2016, 21 CFR 820 and other applicable biotechnology regulations desirable
- Good human relations and oral/written communication skills
- Must have working knowledge of computers, and MS Office applications including MS Word and MS Excel
- Ability to take initiative and prioritize tasks; good time-management, problem prevention, and problem solving skills.
- Must be able to sit for up to 4 hours while using a computer
- Ability to go from site to site by own transportation methods
- Ability to gown and or wear PPE for extended periods of time