Thousand Oaks, California | Contract
In this role, the Senior Engineer/Scientist will support a network-wide effort to more fully characterize our drug products and existing formulation, filling, and finishing processes and equipment, as well as new technology development. Support will include lab scale development studies, authoring technical protocols and assessments, working with external vendors and company cross-functional groups to develop new drug product technologies. The individual will also be responsible for helping to develop and execute remediation plans for any gaps identified. The Senior Engineer /Scientist will also work together with site process development groups and corporate engineering functions to ensure that product, process, and technology lifecycle management process are thorough and robust.
Summary of Job Duties:
- Execute characterization assessments
- Data Gathering – Work with designated subject matter experts (SMEs) to identify key process and product quality attributes and draft protocols/reports to execute studies for new technology development.
- Data Analysis – Review characterization data generated with SMEs to ensure that all potential process/equipment impact on product is well understood and to identify any potential characterization gaps. Present findings to site and corporate leadership.
- Support process risk assessments and risk mitigation plans
- Provide technical expertise (based on characterization assessment) during execution of on-site process risk assessments: provide insight to team on how the product quality attributes and critical process parameters could be affected by existing equipment and machine practices and procedures.
- Develop risk mitigation plans and execute relevant studies for introduction of new drug product technologies
- When not actively engaged in a line characterization or risk assessment, other duties could include:
- Developing plans for assessing remaining F/F lines at company global sites
- Developing plans and conducting studies to mitigate gaps or risks identified during prior assessments
- Act as process SME to drive consistency and robustness in equipment and process lifecycle management across the network
- Work with external vendors to investigate, develop and recommend new drug product technologies
B.S. in Engineering (Chemical, Biochemical, or related). 6+ years experience in support of Commercial Drug Product (DP) processing in specific areas such as GMP Sterile Processing, Process Characterization, Fill Finish Equipment and Technologies, Manufacturing support and Validation.
M.S. in Engineering. 4+ years experience in support of Commercial Drug Product (DP) processing in specific areas such as GMP Sterile Processing, Process Characterization, Fill Finish Equipment and Technologies, Manufacturing support and Validation.
Ph.D. in Engineering. 1+ years experience in support of Commercial Drug Product (DP) processing in specific areas such as GMP Sterile Processing, Process Characterization, Fill Finish Equipment and Technologies, Manufacturing support and Validation.
• Experience troubleshooting issues with Drug Product (DP) / Fill Finish (F/F) characterization, technologies, process design and equipment. Relevant F/F operations include parts washing and preparation, sterilization and depyrogenation, formulation and filtration, aseptic filling, inspection, device assembly, and packaging.
• Experience in drug product manufacturing related capital projects: specifying, qualifying, characterizing and implementing key F/F systems.
• Experience in new and existing DP aseptic and sterile processing technologies (controlled rooms, clean room, RABS, isolators).
• Familiarity with DP packaging processes and technology; familiarity with the qualification and characterization of primary product container systems, secondary packaging and transportation
• Familiarity with risk assessment methodologies (e.g., FMEA) and experience participating in risk assessments.
• Experience providing technical assessments for deviations/non-conformances and related corrective and preventative actions (CAPAs)