Manufacturing Process Engineer

Virtue America; United States; Remoto; USD 45.000 - 70.000; Tempo pieno

Descrizione del lavoro

Virtue America is seeking an Entry-Level Manufacturing Process Engineer to support manufacturing operations in a pharmaceutical environment. The role focuses on process optimization, production efficiency, and continuous improvement within GMP/cGMP frameworks.

The ideal candidate has a background in Chemical/Mechanical/Industrial or Biomedical Engineering and 0–2 years of related experience. This remote-first position offers opportunities to contribute to process validation, data analysis, and

Competenze

• Bachelor's degree in Chemical or Mechanical/Industrial/Biomedical Engineering or related field.
• 0–2 years in manufacturing, process engineering, or pharmaceutical ops.
• Familiar with GMP/cGMP, SOPs, and docs.
• Strong analytical, problem-solving, and communication skills.
• Proficient with Microsoft Office.

Mansioni

• Support development, implementation, and optimization of manufacturing processes.
• Monitor production activities and identify efficiency improvements.
• Assist with process troubleshooting and issue investigations.
• Collect and analyze production data, cycle times, yield, and performance metrics.
• Support validation activities and PPQ/IQ/OQ/PQ as applicable.
• Contribute to CAPA and root cause analyses.
• Prepare process flow diagrams, SOPs, and technical reports.
• Assist with equipment installation, scale-up, and line improvements.
• Collaborate with QA, QC, Engineering, and Validation teams.
• Ensure processes comply with GMP/cGMP, FDA requirements, and GDP.
• Participate in Lean and continuous improvement initiatives.

Conoscenze

GMP knowledge

Analytical skills

Excel

Documentation

Formazione

Bachelor's degree in Chemical Engineering

Bachelor's degree in Mechanical Engineering

Strumenti

Microsoft Excel

PowerPoint

Process mapping tools

Descrizione del lavoro

job Title: Manufacturing Process Engineer – Entry Level

Location: Remote

Employment Type: Full-time

Experience: 0–2 Years

Job Summary

We are seeking an Entry-Level Manufacturing Process Engineer to support manufacturing operations, process optimization, production efficiency, and continuous improvement initiatives within a pharmaceutical or life sciences environment. The ideal candidate will assist with improving manufacturing processes, troubleshooting production issues, analyzing process data, and supporting process validation activities while ensuring compliance with GMP/cGMP, FDA regulations, and quality standards.

This opportunity is suitable for recent graduates with a background in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related field.

Key Responsibilities

• Support the development, implementation, and optimization of manufacturing processes.
• Monitor production activities and identify opportunities to improve efficiency, productivity, and product quality.
• Assist with process troubleshooting and investigation of manufacturing issues.
• Collect and analyze production data, cycle times, yield, and process performance metrics.
• Support process validation, qualification, and process improvement activities.
• Assist with IQ/OQ/PQ documentation and process performance qualification (PPQ), as applicable.
• Participate in root cause analysis and corrective and preventive action (CAPA) activities.
• Prepare and maintain process flow diagrams, SOPs, work instructions, and technical reports.
• Support equipment installation, process scale-up, and manufacturing line improvements.
• Collaborate with Manufacturing, Quality Assurance, Quality Control, Engineering, and Validation teams.
• Ensure manufacturing processes comply with GMP/cGMP, FDA requirements, and Good Documentation Practices.
• Participate in Lean Manufacturing and continuous improvement initiatives.

Required Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Biotechnology, or a related field.
• 0–2 years of experience in manufacturing, process engineering, production, or pharmaceutical operations.
• Recent graduates and candidates with relevant internships or academic projects are encouraged to apply.
• Basic understanding of manufacturing processes, process optimization, and troubleshooting.
• Familiarity with GMP/cGMP, SOPs, and manufacturing documentation.
• Strong analytical, problem-solving, communication, and organizational skills.
• Proficiency in Microsoft Excel, Word, and PowerPoint.