As our microbiologist, you will be responsible for driving results in a fast-paced environment. You will assist in leading and coordinating the activities of a pharmaceutical microbiology group in compliance with cGMP and internal SOPs to support manufacturing and laboratory operation.
- Lead team within the microbiology group to provide the timely, compliant, and accurate testing of raw materials, in-process samples, and finished product, as well as monitoring of environment and critical systems.
- Assist in the onboarding of state-of-the-art technologies and instrumentation (IQ, OQ, PQ, and routine operation).
- Act as Subject Matter Expert in the application of isolator technology.
- Ensure all equipment is calibrated correctly and serviced to support high throughput and full compliance.
- Assist in designing, monitoring, and testing programs and strategically evaluates processes for improvements and optimization.
- Support in activities related to the commissioning of laboratory spaces.
- Write and review test procedures, verification, and validation protocols and reports.
- Assist in the review of laboratory data, including environmental monitoring, microbiology testing, and equipment calibration data.
- Actively participate in cGMP inspections, client visits, and regulatory audits.
- Perform investigations and trending of all microbiological test data, inducing formal communication as to the current control of the GMP areas.
- Lead corrective actions in response to excursions in controlled environmental areas.
- Lead development of testing templates in the Laboratory Information Management System.
- Develop team members through adequate training, mentoring, and motivation, as well as adherence to quality performance standards.
- Perform additional duties as required.
- B.S. in scientific disciplines such as Biochemistry, Biology, Microbiology
- Six years related experience, or equivalent education, experience and training; Master’s degree with four years of similar experience; Doctorate Degree with two years relevant experience knowledge
- Expert knowledge in the development, validation, and verification of microbiological methods and aseptic manufacturing in the pharmaceutical industry
- Expert knowledge of USP/EP/FDA requirements, cGMP, aseptic processing, environmental monitoring techniques, microbial identification, and microbiological quality control testing (sterility, endotoxin, bioburden, HIAC, etc.)
- Experience with inspections/audits by regulatory agencies and clients
TriPharm Services, Inc. is an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. TriPharm complies with all employment eligibility verification requirements of the Immigration and Nationality Act, and all must have the authorization to work in the U.S.