BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Process Engineer to work for an Orange County area biologics company.
- Act as a Subject Matter Expert on the production of a cellular immunotherapy by providing technical support to address real-time process deviations.
- May be asked to provide 24/7 support for both routine and complex deviations.
- Provide timely process and product impact assessments to support Quality product disposition decisions.
- Participate in investigations to identify contributing root cause for product failures and process deviations using a variety of tools including (but not limited to) review of primary data, technical reports, patient history, trending reports and regulatory information.
- Author technical documents for investigations for inclusion in GMP documentation.
- May generate protocols and reports to support process improvement and process validation activities at the IMF.
- Assists with technical transfer activities for processes being transferred to or from the IMF.
- May work on cross-functional project teams to assess the scientific, regulatory, and business impact of process improvement initiatives.
- May assist in the management and implementation of approved process improvement projects at the IMF and contract manufacturing facilities.
- May author, own, or assess change controls related to changes to processes at IMFs and contract manufacturing facilities.
- Participates in regulatory inspections as needed.
- Bachelor’s degree in life sciences required
- 5+ years of experience in cGMP/FDA regulated industry.
- Understanding of statistical analysis of data sets.
- Understanding of Risk Management principles.
- Experience with analyzing data from methods such as ELISA and Flow Cytometry.
- Ability to travel 20% of the time