Process Engineer/Pharma Engineer - Sterile Drug Products
Job Title: Process Engineer/Pharma Engineer – Sterile Drug Products
Location: Largo, Florida, USA
Company: BPI Labs LLC
About Us:
BPI Labs LLC is a rapidly growing pharmaceutical company specializing in sterile injectable medicine research, development, and manufacturing in compliance with US FDA regulations. Our state-of-the-art facility in Largo, Florida, houses advanced sterile fill-finish operations, R&D and quality control laboratories, and a warehouse.
At BPI Labs, we are committed to advancing pharmaceutical manufacturing through innovative technologies such as fully automated robotic systems, gloveless isolators, and single-use systems. Our mission is to deliver the highest quality medicinal products, ensuring the health and safety of patients worldwide.
Position Overview:
We are seeking a motivated and talented Process Engineer/Pharma Engineer to join our team in developing and manufacturing lifesaving sterile drug products such as pre-filled syringes, vials, cartridges and autoinjectors. This position plays a critical role in designing, scaling up, and optimizing manufacturing, labeling, and packaging processes in compliance with current Good Manufacturing Practices (cGMP).
The successful candidate will work with advanced equipment including automated/robotic fillers, filtration and purification systems, sterilizers, isolators, and supporting utilities such as HVAC, steam, compressed air, and USP-quality water systems. The role also involves troubleshooting, process improvement, and collaboration with vendors and cross-functional teams.
Key Responsibilities:
- Design facilities, process equipment, and utilities to support next-generation medicinal products and technologies.
- Attend review meetings; review and approve user requirement specifications, design specifications, functional specifications, and qualification protocols.
- Attend Factory Acceptance Tests (FAT) to ensure equipment and machinery perform as expected.
- Support formulation, manufacturing, filtration, sampling, and in-process testing of sterile drug products using advanced equipment and instruments.
- Set up, operate, and validate sterile fill robots, automation systems, and software.
- Operate, maintain, and validate mixing equipment such as magnetic drive mixers.
- Collaborate with formulation scientists on drug development and experimental design.
- Define and control critical process parameters to ensure consistent product quality.
- Develop manufacturing processes to eliminate contamination and ensure product safety.
- Operate and validate steam sterilizers and perform sterilization qualification studies.
- Prepare and review regulatory submissions (NDAs/ANDAs and CMC Module 3).
- Design and validate terminal sterilization processes.
- Ensure all critical activities comply with SOPs, protocols, and regulatory standards.
Who You Are:
- Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, or Pharmacy with an engineering background.
- Strong verbal and written communication skills with attention to detail.
- Ability to work independently and collaboratively in a team-oriented environment.
- Skilled in troubleshooting equipment and performing complex system tests.
- Familiarity with automation, motion control, pneumatics, and reading P&IDs and schematics.
- Willingness to work in a GMP manufacturing environment, including aseptic cleanrooms and shift operations.
- Eagerness to learn and adapt to new technologies and workflows.
What We Offer:
- An opportunity to work on innovative processes and cutting-edge technologies in a dynamic environment.
- Training and mentorship by experienced professionals to support career growth.
- A chance to make a tangible impact in the production of lifesaving medicines.
Hiring Process:
- Step 1: Review of candidate profiles.
- Step 2: Written and/or verbal interview.
- Step 3: Hiring followed by a 3-month training program with evaluation.
If you are excited about contributing to the development of advanced pharmaceutical technologies and processes, we encourage you to apply and join our mission to deliver high-quality medicinal products.