Job Title: Process Development Engineer
Location: Thousand Oaks, CA (Hybrid – Min 3 days a week in office)
Pay Rate: $40/hr – $42/hr
Job Description:
- We are seeking a dedicated Process Development Engineer to join our Drug Substance Technology Engineering team at our Thousand Oaks facility. This role is pivotal in translating developmental processes into commercial reality for patients through scientific expertise and engineering innovation.
Job Responsibilities:
- Apply cell culture and/or purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing.
- Partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.
- Transfer purification drug substance processes and perform process improvements from the laboratory into the manufacturing facility.
- Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation.
- Offer process validation support for late stage commercial processes.
- Provide routine process monitoring and troubleshooting.
Skills Required:
- Biotech background/experience with cell culture and/or purification experience.
- Strong communication skills – comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.).
- GMP experience highly preferred.
- Ability to execute data trending and statistical process analysis.
- Experience in providing technical direction for process related deviations, CAPAs and change controls.
- Ability to identify and support process related operational excellence opportunities.
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.