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Manufacturing Process Specialist
2 months ago
Job Title:
Process Engineer
Location:
Seattle, WA
Pay Range:
$64 – $74.30/hr
Type:
Contract, Potential for extension or conversion to permanent
Key Responsibilities
1. Develop and refine study protocols and technical documentation, updating process records as necessary to facilitate technology transfer and modifications in processes.
2. Conduct and assist in monitoring data related to manufacturing operations to assess process capability.
3. Assist in production-related investigations, ensuring adherence to internal standards and regulatory guidelines.
4. Evaluate completed batch records to confirm that processes are functioning within the validated parameters.
5. Comprehend and manage tools and templates that quantify the impact and significance of parameters and attributes within the organization and/or Contract Manufacturing Organization (CMO) operations.
6. Ensure that manufacturing processes remain in a controlled state, standardized across the cell therapy network.
7. Promote continuous improvement initiatives for both technical and business processes.
8. Foster and maintain professional relationships with external collaborators.
Qualifications
- Bachelor’s or Master’s degree with 4-7 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology disciplines. (PhD candidates may be overqualified)
- Strong preference for experience in cellular therapies.
- Minimum of 4 years of proficiency in MS Office; familiarity with JMP is a plus.
- At least 4 years of experience in a regulated manufacturing setting is highly desirable.
- A minimum of 1 year of experience in technical or deviation writing.
- Ability to work flexibly across different time zones.
- Excellent communication, writing, organizational, teamwork, and presentation skills.
- Outstanding interpersonal abilities to collaborate with teams across various functions and organizations.
Benefits
System One provides eligible employees with a range of health and welfare benefits, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
