Bilingual Quality Process Engineer – GMP & CAPA

Talnt; Minneapolis (MN); On-site; USD 80,000 - 100,000; Full time

Job summary

Talnt is hiring for a Quality Process Engineer in Minneapolis, MN. This bilingual role demands proficiency in English and Spanish, focusing on improving manufacturing processes and ensuring compliance with regulatory standards.

The ideal candidate has a bachelor's degree in engineering, three to five years of experience in regulated environments, and strong knowledge of quality management systems. Responsibilities include driving quality initiatives, conducting root cause analyses, and developing batch records.

Qualifications

• Three to five years of experience in pharmaceutical or regulated manufacturing.
• Strong working knowledge of GMP, FDA regulations, and ISO 9001.
• Proficiency in producing bilingual technical documentation.

Responsibilities

• Lead the development of manufacturing and packaging batch records.
• Drive quality improvement initiatives through process optimization.
• Conduct root cause analysis to eliminate quality system failures.

Skills

Fluency in English and Spanish

Quality management systems knowledge

Analytical and problem-solving skills

Experience with CAPA and FMEA

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office (Excel, Word, PowerPoint)

Job description

Talnt is hiring for a Quality Process Engineer in Minneapolis, MN. This bilingual role demands proficiency in English and Spanish, focusing on improving manufacturing processes and ensuring compliance with regulatory standards.

The ideal candidate has a bachelor's degree in engineering, three to five years of experience in regulated environments, and strong knowledge of quality management systems. Responsibilities include driving quality initiatives, conducting root cause analyses, and developing batch records.