Job Title: Process Development Engineer
Location: Thousand Oaks, California (Hybrid)
Job Summary: We are seeking a professional to join our team supporting process engineering for human therapeutics. Our focus is on transferring developmental processes to commercial production, delivering innovative solutions for the advancement of clinical and commercial drug substances.
Responsibilities:
- Transfer purification drug substance processes and implement laboratory process improvements into manufacturing facilities.
- Support successful scale-up, process technology transfer, and routine operation of manufacturing processes for clinical and commercial drug substances.
- Provide technical support for process validation activities, process monitoring, troubleshooting, and statistical data analysis.
- Collaborate with manufacturing, quality, and analytical teams to address deviations, CAPAs, change controls, and process-related operational excellence opportunities.
Required:
- Master’s degree or Bachelor’s degree and 2 years of experience or Associate’s degree and 6 years of experience or high school diploma / GED and 8 years of experience.
- Minimum 2 years of experience post-graduation in process engineering or related role.
- Demonstrated knowledge and experience with at-scale biologics purification, including purification processes and equipment, scale-up principles, and commercial cGMP manufacturing facilities.
- Strong understanding of data analysis tools, excellent troubleshooting skills, and proficient verbal and written communication abilities for technical writing and presentations.
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 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.
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