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Manufacturing Process Specialist

2 months ago


Seattle, Washington, United States LanceSoft Full time

Position Title:
Process Engineer

Location: Remote

Contract Duration: 12 months

Role Overview:
The Process Engineer will be responsible for a variety of critical tasks aimed at enhancing manufacturing processes within the cell therapy sector. Key responsibilities include:

  • Developing and revising study protocols and technical documentation to facilitate technology transfer and implement process modifications.
  • Conducting data analysis and monitoring of manufacturing operations to assess process capabilities.
  • Assisting in production-related investigations to ensure adherence to internal protocols and regulatory standards.
  • Evaluating completed batch records to confirm that processes remain within validated parameters.
  • Managing tools and templates designed to evaluate the impact and significance of various parameters within CLIENT and/or CMO operations.
  • Ensuring that manufacturing processes are consistently controlled and standardized across the cell therapy network.
  • Driving continuous improvement initiatives for both technical and operational processes.
  • Building and maintaining professional relationships with external collaborators.

Qualifications and Experience:

  • Bachelor's or Master's degree with 4-7 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering, or a related field such as Cell Biology/Immunology. (PhD candidates may be considered overqualified)
  • Preferred experience in cellular therapies.
  • Proficiency in MS Office with at least 4 years of experience; familiarity with JMP is a plus.
  • A minimum of 4 years in a regulated manufacturing environment is highly desirable.
  • At least 1 year of experience in technical writing or deviation documentation.
  • Ability to work flexibly across different time zones.
  • Strong communication, writing, organizational, teamwork, and presentation skills.
  • Exceptional interpersonal abilities to collaborate effectively with cross-functional teams.

Employee Benefits:

At LanceSoft, full-time employees working a minimum of 30 hours per week are eligible for a comprehensive benefits package, which includes:

  • Multiple options for Medical Insurance
  • Dental and Vision Insurance
  • 401k Contributions
  • Critical Illness Insurance
  • Voluntary Permanent Life Insurance
  • Accident Insurance
  • Additional Employee Perks

About LanceSoft:
LanceSoft is recognized as one of the largest staffing firms in the United States, committed to fostering global cross-cultural connections that enhance the careers of our employees and support the businesses of our clients. We leverage our extensive global network to connect organizations with the right talent and individuals with the right opportunities, ensuring an unbiased approach.

As an equal opportunity employer, LanceSoft prohibits discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by applicable laws. This policy is applicable to all employment practices within our organization.