EM Microbiologist - Swing Shift (3PM-12AM)

Nivagen Pharmaceuticals•Sacramento, CA

13d•$75,000 - $85,000•Onsite

About The Position

Nivagen Pharmaceuticals is hiring an EM Microbiologist for its Sacramento, California location. The role ensures pharmaceutical products meet quality standards during manufacturing through real-time monitoring, sampling, testing, and documentation, while ensuring production complies with Good Manufacturing Practices and regulatory requirements. The position develops and validates microbiological test methods, maintains detailed records, and prepares reports, protocols, and standard operating procedures. It collaborates with cross-functional teams on project objectives and timelines, identifies laboratory process improvements, and trains and mentors microbiology staff. The role performs routine and non-routine environmental monitoring in classified cleanrooms, including sampling during aseptic filling in Grade A and Grade B (ISO 5 and 6) environments. It also samples utilities such as portable water, purified water, water for injection, pure steam, compressed gas, and nitrogen. The employee follows cGMP and company procedures, participates in audits as needed, and maintains accurate records in accordance with good documentation practices. This position is assigned to the swing shift, 3 PM to 12 AM. It requires talking and hearing, bending at the waist and knees, twisting at the trunk, lifting up to 25 pounds, and wearing laboratory protective gowning and equipment, including goggles, face shields, respirators, and protective gloves.

Requirements

Bachelor’s degree in microbiology, biology, or a related field.
At least 3 years of experience in a microbiology laboratory.
Strong knowledge of microbiological testing techniques, methods, and equipment.

Nice To Haves

Master’s degree.
Previous experience in a pharmaceutical or compounding environment.
Experience with United States Pharmacopeia compendial testing and FDA and cGMP regulatory requirements.
Experience with microbiological method development and validation, including sterility testing, endotoxin testing, disinfectant efficacy studies, water testing, environmental monitoring, microbial limit testing, PET, microbiological hold-time validation, and container closure integrity.

Responsibilities

Ensure compliance with regulatory standards, current Good Manufacturing Practices (cGMP), and company policies and procedures; participate in internal and external audits as needed.
Conduct routine and non-routine environmental monitoring in classified cleanrooms, including non-viable, viable, contact, and swab surface sampling.
Perform environmental monitoring during aseptic filling production while following aseptic behaviors and cleanroom gowning requirements in Grade A and Grade B (ISO 5 and 6) environments.
Conduct microbiological sampling of utilities, including portable water, purified water, water for injection, pure steam, compressed gas, and nitrogen.
Maintain accurate, detailed records of microbiological testing and analysis in accordance with good documentation practices (cGDP).
Prepare and review reports, protocols, and SOPs related to microbiological activities.
Participate in microbiology-related projects, including method transfers, validations, and investigations.
Collaborate with cross-functional teams to achieve project objectives and timelines.
Train and mentor microbiology staff and promote continuous learning and development.
Identify opportunities for laboratory process improvements and implement best practices and innovative solutions to improve efficiency and effectiveness.
Perform other duties as assigned.