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!