The Role
Support scientific and technical activities in a regulated manufacturing environment. Lead process development and improvement efforts, execute and document validation (including filling validation), produce technical documentation, and ensure compliance with regulatory requirements. Collaborate cross-functionally to drive process robustness and validation-ready processes.
Summary Generated by Built In
We are seeking a Process Development Sr. Scientist to support scientific and technical activities within a regulated manufacturing environment. The ideal candidate will possess a strong scientific background, experience with validation activities, technical documentation, and the ability to contribute to process development, process improvement, and compliance-driven initiatives.
Requirements
- Education in Engineering or Microbiology.
- Doctorate (PhD, PharmD, or MD); or Master’s degree with 3+ years of scientific experience; or Bachelor’s degree with 5+ years of scientific experience.
- Validation experience in a highly regulated industry.
- Filling validation experience.
- Experience working on technical documentation.
- Fully bilingual (English and Spanish)
Skills Required
- Education in Engineering or Microbiology.
- Doctorate (PhD, PharmD, or MD); or Master's degree with 3+ years scientific experience; or Bachelor's degree with 5+ years scientific experience.
- Validation experience in a highly regulated industry.
- Filling validation experience.
- Experience working on technical documentation.
- Fully bilingual 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.
