Process Engineer

Virtue America; United States; On-site; USD 55,000 - 85,000; Full time

Job summary

Virtue America is seeking an Entry-Level Process Engineer to support pharmaceutical manufacturing processes in a regulated environment.

You will assist with process optimization, validation, deviation investigations, and CAPA activities while collaborating with QA, QC, and Validation teams to ensure compliance and continuous improvement.

Qualifications

• Bachelor’s degree in a related technical field.
• Familiarity with cGMP, SOPs, process validation, equipment qualification, and technical documentation.
• Fresh graduates or 0–2 years of experience encouraged.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills.

Responsibilities

• Support monitoring, evaluating, and improving pharmaceutical and life sciences manufacturing processes.
• Assist with process optimization to enhance efficiency, product quality, consistency, and productivity.
• Assist with process validation, qualification, commissioning, and related engineering activities.
• Support investigations related to process deviations, equipment issues, and manufacturing problems.
• Collect and analyze process data to identify trends and opportunities for improvement.
• Prepare and maintain SOPs, process specifications, technical reports, batch documentation, and engineering records.
• Assist with deviation investigations, root-cause analysis, risk assessments, and CAPA activities.
• Ensure process engineering activities comply with cGMP, FDA, GDP, and applicable quality requirements.
• Work with QA, QC, Manufacturing, Validation, Maintenance, and Engineering teams to support production requirements.
• Participate in Lean, Six Sigma, process improvement, and operational excellence initiatives.
• Follow applicable EHS procedures and support safe operation of manufacturing processes and equipment.

Skills

Fresh graduates

0–2 years experience

Analytical skills

Problem-solving

Communication skills

Pharma processes

CAPA

cGMP

Regulatory awareness

Education

Bachelor's degree in Chemical Engineering or Life Sciences

Job description

We are seeking a motivated and detail-oriented Entry-Level Process Engineer to support manufacturing processes, process optimization, troubleshooting, and continuous improvement activities within a regulated pharmaceutical or life sciences environment. The role will collaborate with Manufacturing, QA, QC, Engineering, and Validation teams to ensure processes are efficient, reliable, and compliant with regulatory standards.

Key Responsibilities:

• Process Engineering Support: Assist with monitoring, evaluating, and improving pharmaceutical and life sciences manufacturing processes.
• Process Optimization: Support process improvement initiatives to enhance efficiency, product quality, consistency, and productivity.
• Process Validation: Assist with process validation, qualification, commissioning, and related engineering activities.
• Troubleshooting: Support investigations related to process deviations, equipment issues, and manufacturing problems.
• Data Analysis: Collect and analyze process data to identify trends, performance gaps, and opportunities for improvement.
• Documentation Management: Prepare and maintain SOPs, process specifications, technical reports, batch documentation, and engineering records.
• Deviation & CAPA Support: Assist with deviation investigations, root-cause analysis, risk assessments, and CAPA activities.
• Regulatory Compliance: Ensure process engineering activities comply with cGMP, FDA, GDP, and applicable quality requirements.
• Cross-Functional Collaboration: Work with QA, QC, Manufacturing, Validation, Maintenance, and Engineering teams to support production requirements.
• Continuous Improvement: Participate in Lean, Six Sigma, process improvement, and operational excellence initiatives.
• Safety & Compliance: Follow applicable EHS procedures and support safe operation of manufacturing processes and equipment.

Required Skills:

• Bachelor’s degree in Chemical Engineering, Biotechnology, Pharmaceutical Engineering, Biochemical Engineering, Life Sciences, or a related technical field.
• Basic understanding of pharmaceutical and life sciences manufacturing processes.
• Familiarity with cGMP, SOPs, process validation, equipment qualification, and technical documentation.
• Basic knowledge of process troubleshooting, root-cause analysis, and CAPA.
• Understanding of process flow, manufacturing operations, and basic data analysis.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills.
• Strong attention to detail and ability to work in a regulated environment.
• Fresh graduates and candidates with 0–2 years of relevant experience are encouraged to apply.