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Principal Process Engineer

2 months ago

Woburn, United States ClinLab Staffing Full time

We are seeking an experienced and motivated Principal Process Development Engineer or Scientist to join our Product and Process Development team. As an expert in process development, this individual will provide technical leadership for manufacturing process development, new product introduction, and technical support. This role requires a strong team player and change implementer to drive robust and scalable reagent manufacturing processes. The candidate will collaborate cross-functionally with Manufacturing, R&D, and QA/RA to achieve company and project goals.

Responsibilities:

  • Provide expert technical leadership in immunoassay reagent manufacturing process development and new product introduction.
  • Establish reagent manufacturing process requirements to meet product specifications.
  • Translate technical requirements into defined and documented manufacturing specifications and procedures.
  • Lead the development, optimization, and scale-up of reagent manufacturing processes to achieve product launch and business goals.
  • Solve challenging, interdisciplinary technical problems at the interface of biology, chemistry, engineering, and materials science.
  • Develop test methods to assess raw material quality.
  • Define, source, install, and qualify manufacturing equipment to support process and product volume requirements in collaboration with internal stakeholders and external suppliers.
  • Independently design, develop, and execute experiments to justify technical decisions.
  • Plan, develop, and coordinate multiple product and process development or manufacturing improvement projects with a high degree of creativity, foresight, and mature judgment.
  • Become a subject matter expert in reagent manufacturing processes, including root cause investigations, validations, and other internal processes.
  • Provide general guidance, career development, and training to lower-level support staff.

Qualifications:

  • Work experience in Biotech, Life Sciences, or Pharmaceutical industries preferred.
  • Hands-on experience with molecular biology or microbiology techniques.
  • Experience in reagent/consumables production and product development.
  • Proficiency in applying statistical tools including DOE, Gage R&R, process capability, and Statistical Process Control.
  • Demonstrated ability to solve challenging, interdisciplinary technical challenges.
  • Excellent interpersonal skills and the ability to function effectively in a team environment.

Education and Experience:

  • PhD in Engineering, Biology, Chemistry, or related disciplines with 5+ years of experience.