Overview
Skills
Job Details
Job Title: Senior Engineer Cell Therapy Technical Operations
Job ID: 25-08697
Location: Seattle-Dexter, WA
Duration: 12 months on W2 contract
Schedule: Normal Business hours
Hybrid: (50%+ days onsite required, days of week are flexible)
Job Overview:
Seeking a proactive Senior Engineer with experience in CAR-T/cell therapy manufacturing and lifecycle management. This role leads global product lifecycle strategy and process improvements for commercial CAR-T therapies.
Key Responsibilities:
- Drive lifecycle plans and implement process changes for cell therapy products.
- Lead cross-functional projects improving robustness, scalability, and cost efficiency (COGs).
- Analyze critical variables using Excel, JMP, or Spotfire; support regulatory batch history sections.
- Author validation documents and technical content for regulatory submissions.
- Lead technical strategy, ensure cGMP compliance, and manage change controls, CAPAs, SOPs.
- Collaborate across manufacturing sites and CMC teams to ensure best-in-class execution.
Top Skills Required:
- Proven leadership of cross-functional teams.
- Expertise in CAR-T or autologous T-cell therapy processes.
- Strong knowledge of SOPs, deviations, and quality systems.
- Experience with lifecycle management and process improvement in biotech.
- Strong communication, data analysis, and problem-solving skills.
Qualifications:
- Bachelor s/Master s in Chemical/Biomedical Engineering or Life Sciences.
- 5+ years biotech experience; cell therapy and cGMP experience preferred.
- Proficiency in Excel, JMP, Spotfire is a plus.
Compensation:
The hourly rate for this position is between $62.00-$69.00 per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits:
Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.