Quality Assurance Specialist
Frida
Process Engineer
PSC Biotech Corporation
full-time
Posted on:
Origin: • 🇺🇸 United States • Colorado
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Lead the design and optimization of pharmaceutical manufacturing process equipment and systems
- Plan and conduct experiments (Design of Experiments, DOE) to determine parameters and analyze processes, equipment, and system optimization
- Oversee the design, installation, and validation of manufacturing systems and equipment such as filling machines and packaging lines
- Ensure product quality, validate process parameters, and improve manufacturing efficiency
- Collaborate with cross-functional teams including R&D, Quality, Validation, and Operations to enable product scale-up and transfer
- Develop and review engineering documentation including P&IDs, process flow diagrams, equipment specifications, and installation protocols
- Manage equipment selection, procurement, installation, and commissioning
- Troubleshoot and resolve process-related issues to ensure consistent product quality and compliance
- Ensure all process designs meet cGMP, FDA, and other regulatory requirements
- Support continuous improvement initiatives to enhance manufacturing efficiency, reliability, and safety
- Additional responsibilities as required.
Requirements
- Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, or related field
- 5+ years of experience in process and design engineering within the pharmaceutical manufacturing industry
- Synthesis process, cleavage and deprotection to purification and lyophilization
- Strong understanding of pharmaceutical process equipment (e.g., filling machines, mixers, reactors)
- Strong knowledge of DOE methodologies and statistical analysis tools (e.g., JMP, Minitab)
- Advanced knowledge of regulatory standards including cGMP, FDA, and ICH guidelines
- Experience with automation systems and process control
- Knowledge of validation protocols (IQ/OQ/PQ)
- Excellent problem-solving, project management, and communication skills
- Ability to work independently and in a team-oriented environment
- Excellent attention to detail with commitment to quality and compliance
- Willingness and ability to travel as needed for project assignments and client engagements
