Microbiologist - Sterile Injectable Drug Products
Job Title: Microbiologist – Sterile Injectable Drug Products (4 Positions)
Location: Largo, Florida, USA
Company: BPI Labs LLC
Employment Type: Full-Time | On-site | 2-Shift Operation
Department: Quality Control – Microbiology
About Us
BPI Labs LLC is a rapidly growing pharmaceutical company specializing in the research, development, and manufacturing of sterile injectable medicines, in full compliance with USFDA regulations. Based in Largo, Florida, our state-of-the-art sterile manufacturing facility is equipped with advanced robotic aseptic fill-finish systems, gloveless isolators, and single-use systems. We are committed to pioneering next-generation pharmaceutical manufacturing to produce the highest quality injectable drug products that enhance patient health and safety globally.
The Opportunity
We are looking for highly motivated and skilled Microbiologists to join our team in a Current Good Laboratory Practices (cGLP) environment, operating under the oversight of the FDA and other global regulatory agencies. You will play a crucial role in supporting sterile parenteral manufacturing through microbiological testing, environmental monitoring, method development, and ensuring regulatory compliance in a cutting-edge facility.
Key Responsibilities (include but are not limited to):
- Sampling, testing, and reporting of Purified Water and Water for Injection (WFI) in compliance with USP/EP.
- Environmental Monitoring of cleanrooms via Active Air, Passive Air, and Surface Sampling.
- Preparation and suitability testing of bacterial culture media.
- Handling, isolation, inoculation, and identification of bacterial and fungal isolates.
- Performing microbial limit tests and Bacterial Endotoxin Testing (BET) on APIs, excipients, and finished products.
- Conducting sterility testing on in-process and final drug products.
- Participation in Aseptic Process Simulations (media fills) and microbial analysis.
- Calibration, operation, and maintenance of lab equipment: autoclaves, incubators, pH meters, balances, colony counters, laminar air flow units, etc.
- Preparation, usage, and efficacy testing of disinfectants.
- Documentation review, deviation/OOS/OOT notification, and compliance with cGMP, cGLP, and safety protocols.
Qualifications
- Bachelor’s or Master’s degree in Microbiology or a related life sciences discipline.
- Minimum 1–3 years of experience in a microbiology lab, preferably within a sterile pharmaceutical manufacturing environment.
- Strong understanding of cGLP/cGMP standards and regulatory requirements (FDA, USP, EP).
- Detail-oriented with excellent analytical, verbal, and written communication skills.
- Ability to troubleshoot microbiological equipment and testing issues independently.
- Experience working in GMP aseptic cleanroom environments is a plus.
- Willingness to work in two-shift operations in a manufacturing setting.
Ideal Candidate Attributes
- Self-motivated, collaborative, and process-oriented.
- Comfortable learning and applying new technologies and digital systems.
- Able to work closely with teams in Quality Control, Manufacturing Science & Technology, and R&D.
- Demonstrated commitment to continuous learning, quality, and compliance.
Hiring Process
- Resume Review
- Written and/or Verbal Interview
- Hiring & 3-Month Training Program with expert supervision and performance evaluation.
Why Join BPI Labs?
- Be part of a forward-thinking team transforming sterile injectable manufacturing with cutting-edge automation and robotic systems.
- Work in a collaborative, high-growth environment focused on quality, innovation, and patient safety.
- Competitive compensation, opportunities for professional growth, and exposure to advanced aseptic processing technologies.
Interested candidates are encouraged to apply today.
Join us in delivering the future of sterile injectable medicines.