What are the responsibilities and job description for the Microbiologist I position at Penn Life Sciences?
Job Description
Department
Microbiological Services
Job Title
Microbiologist I
FLSA Status
Exempt
Reports To
Microbiology Manager
Specialization (If any)
Bachelor of Science is preferred
Science or related field
Experience Requirement
2-5 years of scientific experience is preferred.
Company Description
Penn Life Sciences
Penn Life Sciences
Department
Microbiological Services
Job Title
Microbiologist I
FLSA Status
Exempt
Reports To
Microbiology Manager
- Role Purpose:
- Key Duties & Responsibilities:
- Responsible for cGMP compliance in Microbiology Department.
- Provide microbiological support to maintain and improve process controls.
- Provide secondary support to Quality Assurance programs for the manufacture of aseptically filled and oral dose pharmaceutical products.
- Sampling raw materials, in-process material, environment and utilities for microbiological analysis.
- Bioburden monitoring of Raw Materials, In-process samples, Manufacturing environment, Utilities and supporting areas.
- Sterility Testing of finished products and In-process samples
- Bacterial Endotoxin Testing of Raw Materials, Finished products and Container/Closures.
- Antimicrobial Effectiveness Testing of finished pharmaceutical products
- Cleaning and disinfection.
- Stability study support.
- Liquid Particulate Matter testing of Finished Drug products.
- Container-closure integrity testing.
- Colony Morphology, Gram Staining and Microbial Identification.
- Assist in Laboratory Investigations related to OOS/OOT results.
- Responsible for Laboratory cleanliness and biohazard removal
- Actively participates in the Laboratory Training Program
- Maintaining Laboratory Inventory (Media, Reagents, Sterile Consumables, Reference Standard and Reference Cultures)
- Media preparation and Microbiological Control
- Preservation of Microbial Isolates
- Provide support for conducting Gowning Qualification studies to support Aseptic Manufacturing operations
- Supports the Aseptic Manufacturing process by conducting Microbial Monitoring of Manufacturing Environment, Surfaces, Personnel and Process utilities (Pharmaceutical Water and Compressed Air)
- Trending the Bioburden results obtained from Environment and Utility monitoring on a regular basis
- Support Microbial Risk Assessment and mitigation process.
- Support the validation of Steam Sterilization (Pharmaceutical Water and Compressed gases), Manufacturing Area (Air and Surfaces), Personnel, Cleaning and Disinfection and Aseptic Manufacturing Process which includes Aseptic Process Simulations.
- Document Microbiological Test details and Results, including in applicable interface (Electronic and Paper Documentation) according to Laboratory procedures.
- Initiate Laboratory Investigation in the event of OOS/OOT results.
- Excellent written and oral communication skills
- MS Office applications
- Typical Supervisory Responsibility:
- Education & Experience:
Specialization (If any)
Bachelor of Science is preferred
Science or related field
Experience Requirement
2-5 years of scientific experience is preferred.
- Technical competencies/ Certifications/ Licenses:
- Strong communication and writing skills including demonstrating proficiency in English.
- Will be required to be fully gowned, including eye and facial covering in sterilized garments and be present in a clean room for hours at a time.
- Physical demand and Work environment:
- Physical demands:
- Work environment:
Company Description
Penn Life Sciences
Penn Life Sciences