Quality Process Engineer (bilingual)
On-siteMinneapolis, Minnesota, United States
Job Summary
Lead bilingual Spanish and English development, review, and maintenance of manufacturing and packaging batch records, SOPs, and validation protocols. Drive quality improvement initiatives through process optimization, equipment performance enhancements, and root cause analysis using structured problem-solving methodologies. Support and execute process validation, equipment qualification, and cleaning validation activities in regulated environments while developing and monitoring Corrective and Preventive Actions. Investigate production and testing deviations, document findings, and establish compliant procedures aligned with GMP requirements. Represent the quality organization in cross-functional meetings to independently resolve complex issues and train personnel on quality procedures and compliance. Ensure ongoing adherence to current Good Manufacturing Practices, safety standards, and environmental regulations.
Required Qualifications
- Bachelors degree in Engineering or a related technical discipline
- Three to five years of experience in pharmaceutical, cosmetic, personal care, or regulated manufacturing environments
- Fluency in written and spoken English and Spanish, with experience producing bilingual technical documentation
- Strong working knowledge of quality systems, including GMP, FDA regulations, ISO 9001, and industry compliance standards
- Hands-on experience with CAPA, FMEA, statistical process control, and quality management systems
- Proven experience developing manufacturing and packaging batch records, validation protocols, and qualification documentation
- Excellent analytical, critical thinking, and problem-solving skills with a strong attention to detail
- High ethical standards, professionalism, and the ability to work independently in a fast-paced, cross-functional environment
- Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint
Desired Qualifications
- Masters degree in Engineering or a related technical field
- One to two years of industry experience in pharmaceuticals or cosmetics combined with an advanced degree
- ASQ Certified Quality Engineer certification or similar quality certification
- Experience supporting audits, inspections, and regulatory submissions in regulated manufacturing settings
- Demonstrated success leading continuous improvement initiatives and cross-functional quality projects
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