The Role
Develops practical digital tools, dashboards, and process improvements to address ambiguous operational challenges. Supports drug product manufacturing, characterization studies, engineering runs, PPQ, validation deliverables, and manufacturing readiness. The role may involve data analysis, statistical evaluation, GMP documentation, validation principles, automation tools, and collaboration across manufacturing activities. English and Spanish bilingual proficiency is preferred.
Summary Generated by Built In
We are seeking a Sr. Engineer who is self-driven, comfortable working with ambiguous business needs, and able to translate operational challenges into practical digital tools, dashboards, or process improvements.
Requirements
- Education: Doctorate or Masters + 2 years of Engineering experience or Bachelors in Engineering + 4 years of Engineering experience.
Preferred qualifications include:
- Experience with data analysis, dashboard development, statistical evaluation, GMP documentation, validation principles, and process improvement.
- Working knowledge of AI-enabled or automation tools such as Python, Codex, Power Automate, SQL, or VBA.
- Experience supporting Drug Product manufacturing, characterization studies, engineering runs, PPQ, validation deliverables, or manufacturing readiness activities.
- Fully Bilingual (English and Spanish).
Skills Required
- Doctorate in Engineering
- At least 2 years of Engineering experience with a Doctorate or Master’s degree
- Bachelor’s degree in Engineering and at least 4 years of Engineering experience
- Experience with data analysis, dashboard development, statistical evaluation, GMP documentation, validation principles, or process improvement
- Working knowledge of Python, Codex, Power Automate, SQL, or VBA
- Experience supporting drug product manufacturing, characterization studies, engineering runs, PPQ, validation deliverables, or manufacturing readiness activities
- Fluency in English and Spanish
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
