Process Development Engineer

Process Development Engineer

Location: Santa Clara, CA

Duration: 12 months with possible extension

Pay Rate: $65–$70/hr on W2.

A leading global biotechnology company in the sequencing solutions industry is seeking an experienced Process Development Engineer to join their team. This position offers a unique opportunity to contribute to high-impact manufacturing processes for cutting-edge diagnostic products. If you're passionate about improving manufacturing robustness, enhancing yields, and supporting process optimization, this role could be your next great challenge.

Responsibilities:

Technical Support: Troubleshoot manufacturing processes and lead improvement initiatives.

Conduct process characterization and capability studies, identifying critical parameters.

Write and maintain production documentation, ensuring compliance with quality standards.

Implement In-Process Controls (IPCs) and track critical quality attributes (CTQs).

Lead root cause investigations using structured methodologies (e.g., Kepner-Tregoe, 5 Whys, Fishbone).

Plan and execute Design of Experiments (DOE) and perform statistical analysis with tools like JMP or Minitab.

Drive continuous improvement using Lean Six Sigma principles to reduce costs and increase efficiency.

Collaborate across teams to ensure product supply integrity and compliance with quality standards.

Qualifications:

Bachelor's degree in Engineering (Biomedical, Chemical, Mechanical, or related discipline).

5+ years of experience in regulated manufacturing (medical device, IVD, or similar).

Proficiency in DOE, SPC, and statistical analysis tools (e.g., JMP, Minitab).

Experience with microfluidics, surface chemistry, or reagent formulation is a plus.

Familiarity with ERP systems (e.g., SAP) for managing production documentation.

Lean Six Sigma Green Belt (preferred, or attainable within 12 months).

Skills & Attributes:

Strong communication and collaboration skills.

Ability to manage technical projects independently.

Expertise in implementing in-process controls and CTQ metrics.

Knowledge of structured root cause analysis techniques (e.g., Fishbone, 5 Whys).

Why Apply?

This is a rare opportunity to work with a top-tier biotechnology company at the forefront of sequencing technology. We want to hear from you if you're passionate about improving manufacturing processes and product quality!