BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Process Engineer to work for a leading San Diego biotechnology company.
- Interacts with clients to ensure successful technical transfer and integration of lyophilization processes into the manufacturing department.
- Provides technical and theoretical support to manufacturing staff within area of specialty.
- Writes and reviews SOPs, compliance, change controls, risk assessments and other technical and quality related documentation.
- Employs high level technical expertise to investigate and resolve complex matters related to lyophilization equipment and processes.
- Responsible for continuous improvement to existing equipment and process procedures to enhance safety, quality and productivity.
- Researches and implements new equipment, methods and technologies for the lyophilization of parenteral products.
- Trains others on equipment and procedures associated with lyophilization.
- Coordinates & oversees the activities of all cross functional departments (Manufacturing, Metrology, Validation and Quality) to successfully complete all projects.
- Assists with re-qualification and validation of equipment and procedures.
- Assists equipment specialists in the routine maintenance of production equipment as needed.
- BS degree in Life Science discipline or equivalent.
- Minimum of 8 years of relevant experience in a parenteral manufacturing environment with at least 5 years in lyophilization.
- Experience operating and troubleshooting automated lyophilization, tray loading/unloading, and vial handling equipment.
- Extensive knowledge of the processes and qualification for CIP, SIP, vacuum integrity testing, media simulation and parenteral lyophilization.
- Demonstrated knowledge and experience with low temperature rotary screw refrigeration systems, lyophilizer vacuum systems, helium leak detection, and the instrumentation associated with routine lyophilizer performance monitoring, functional control, and qualification activities.
- Experience with lyophilizer loading/unloading using RABS and full isolator environmental barriers.
- Demonstrated ability to understand and apply complex technical concepts to manufacturing/production methodology.
- Must have a high level of knowledge in global pharmaceutical cGMP’s.
- Must be able to develop solutions to complex problems that require an in-depth degree of ingenuity, creativity, and innovation.
- Detail oriented with strong written and verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Must be familiar with Microsoft Office applications.