ufacturing support, or production systems within a regulated environment (biotech, pharmaceutical, or similar).
Technical Knowledge
Familiarity with automation systems, process equipment, and continuous improvement methodologies (Lean Six Sigma, Kaizen, root cause analysis).
Problem-Solving Skills
Demonstrated ability to troubleshoot manufacturing issues, implement corrective/preventive actions (CAPA), and drive process optimization.
Cross-Functional Collaboration
Proven experience working with operations, quality, and maintenance teams to deliver results in a fast-paced environment.
Regulatory / GMP Knowledge
Understanding of cGMP, compliance, and documentation practices for regulated industries.
Requirements
- Doctorate or Masters + 2 years of Engineering experience or
Bachelors in Engineering + 4 years of Engineering experience (Chemical, Mechanical, Industrial or Biotechnology Engineering)
Strong communication, adaptability to change
Bilingual (Spanish/English)
Skills Required
- Doctorate or Masters plus 2 years engineering experience, OR Bachelors plus 4 years (Chemical, Mechanical, Industrial, or Biotechnology Engineering)
- Hands-on experience in process engineering, manufacturing support, or production systems within regulated (biotech/pharma) environments
- Familiarity with automation systems and process equipment
- Experience with continuous improvement methodologies (Lean Six Sigma, Kaizen, root cause analysis)
- Proven ability to troubleshoot manufacturing issues, implement corrective/preventive actions (CAPA), and drive process optimization
- Understanding of cGMP, compliance, and regulated-industry documentation practices
- Strong communication skills and adaptability to change
- Bilingual in Spanish and English
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.
