Process Engineer II

仕事内容

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As a (Process Engineer II), you are responsible for:

Key Responsibilities:

• Design studies to enhance process understanding and optimize performance parameters.
• Collaborate in execution of experiments in the Process Design (PDe) lab to support process development, optimization, and characterization.
• Analyze in-process and analytical data to monitor trends and assess process robustness and consistency.
• Support technology transfer (TT) activities, including training MSAT and manufacturing personnel on process execution and providing support to manufacturing teams as needed.
• Execute occasional studies in GMP manufacturing environments to support regulatory filings.
• Apply statistical tools, including Design of Experiments (DOE), to identify and evaluate critical process parameters.
• Draft and review technical documents, including SOPs, manufacturing batch records, protocols, technical reports, and risk assessments.
• Prepare and present technical findings to leadership and cross-functional teams.
• Perform other duties as assigned.

Basic Qualifications:

• Bachelor’s degree in chemical engineering, Biomedical Engineering, Biotechnology, or a related field with 4+ years of relevant experience, or a Master’s degree with 2+ years of experience.

Preferred Qualifications:

• Demonstrated experience in pharmaceutical manufacturing, process development, and technology transfer; cell therapy experience strongly preferred.
• Hands-on cell culture and aseptic processing experience, including:
  • Cell passaging
  • Cell Cryopreservation
  • Media formulation
  • Aseptic techniques in a biosafety cabinet (BSC)
  • Cell counting and reagent preparation
  • Experience with bioreactors is a plus.
• Solid understanding of cGMP & cGDP regulations and compliance expectations.
• Experience with statistical design and execution of experiments.
• Strong foundation in scientific and engineering principles related to cell therapy manufacturing.

Skills & Competencies:

• In-depth knowledge of biopharmaceutical manufacturing and aseptic processing.
• Strong analytical thinking, troubleshooting, and problem-solving skills.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to collaborate and communicate effectively with team members and cross-functionally
• Ability to operate independently and adapt to a fast-paced, evolving work environment.
• Self-motivated, accountable, and able to take initiative.
• Proficient in Microsoft Office and data analysis tools (e.g. JMP, SAS, Prism, etc)
• Positive attitude, high energy, and a collaborative mindset.
• Comfortable working cross-functionally across research, Quality, MSAT and manufacturing teams.