Qualifications

• BS in Biomedical Engineering or relevant field required; MS preferred with less experience.
• 5 years of experience in GxP environments or 2 years with an MS.
• Experience in GxP automation commissioning and lifecycle management required.
• Knowledge of GxP Fill/Finish applications is essential.
• Proficiency with sensors, circuit design, and automation control systems preferred.
• Strong background in biologics within the pharmaceutical industry preferred.
• Effective communication and leadership skills across multifunctional teams are necessary.

Responsibilities

• Lead equipment qualification activities in support of drug product manufacturing and R&D.
• Facilitate technical discussions to resolve issues with equipment suppliers and project challenges.
• Design and implement automation solutions for manufacturing operations.
• Enhance understanding of process impacts on drug products for scientific excellence.
• Support internal Fill/Finish activities related to stability development batch manufacturing.
• Drive continuous improvement initiatives in production processes.
• Develop skills in process engineering, including multiphysics software and data analysis.

Benefits

• Comprehensive medical coverage, including dental and vision options.
• Life and disability insurance coverage.
• 401(k) plan with company matching contributions.
• Paid vacation and holidays.