Senior Process Engineer

Novozen Healthcare LLC; Oregon (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Novozen Healthcare LLC is seeking an experienced Process Engineer to support pharmaceutical manufacturing operations, process optimization, validation, technology transfer, and continuous improvement initiatives. The ideal candidate will have hands-on experience in GMP-regulated environments and the ability to collaborate with Manufacturing, MSAT, Quality, Validation, and Engineering teams.

Responsibilities include supporting deviations, CAPA, change controls, risk assessments, and analyzing

Qualifications

• Requires a bachelor’s degree in a related engineering field.
• 3+ years of experience as a Process Engineer in GMP-regulated environments.
• Strong knowledge of process engineering, validation, and improvement.

Responsibilities

• Provide process engineering support for pharmaceutical manufacturing operations.
• Develop, optimize, and improve manufacturing processes to enhance quality, efficiency, and reliability.
• Support process validation, qualification, and continued process verification (CPV) activities.
• Support technology transfer and scale-up of manufacturing processes.
• Troubleshoot manufacturing and process-related issues and perform root cause analysis.
• Support deviations, CAPA, change controls, and risk assessments.
• Analyze process data and manufacturing trends to identify opportunities for continuous improvement.
• Develop and review technical documentation, SOPs, batch records, process specifications, and validation documents.
• Collaborate with Quality and Manufacturing teams to ensure compliance with GMP/cGMP and FDA requirements.

Skills

Process engineering

GMP/cGMP knowledge

Cross-functional collaboration

Troubleshooting

Process validation

Technology transfer

Risk assessments

Education

Bachelor's degree in Chemical/ Biochemical/ Mechanical/ Pharmaceutical Engineering

Tools

Documentation management

Job description

Our client is seeking an experienced Process Engineer to support pharmaceutical manufacturing operations, process optimization, validation, technology transfer, and continuous improvement initiatives. The ideal candidate will have hands‑on experience in a GMP‑regulated pharmaceutical or biopharmaceutical manufacturing environment and the ability to work closely with Manufacturing, MSAT, Quality, Validation, and Engineering teams.

Key Responsibilities

• Provide process engineering support for pharmaceutical manufacturing operations.
• Develop, optimize, and improve manufacturing processes to enhance quality, efficiency, and reliability.
• Support process validation, process qualification, and continued process verification (CPV) activities.
• Support technology transfer and scale‑up of manufacturing processes.
• Troubleshoot manufacturing and process‑related issues and perform root cause analysis.
• Support deviations, CAPA, change controls, and risk assessments.
• Analyze process data and manufacturing trends to identify opportunities for continuous improvement.
• Develop and review technical documentation, SOPs, batch records, process specifications, and validation documents.
• Collaborate with Quality and Manufacturing teams to ensure compliance with GMP/cGMP and FDA requirements.
• Support equipment commissioning, qualification, and process startup activities.
• Participate in cross‑functional projects and provide technical recommendations to project teams.
• Identify process risks and implement appropriate mitigation strategies.
• Support continuous improvement initiatives to improve process robustness, yield, throughput, and manufacturing efficiency.

Required Qualifications

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related field.
• 3+ years of experience as a Process Engineer in pharmaceutical, biopharmaceutical, or other GMP‑regulated manufacturing environments.
• Strong knowledge of process engineering, process validation, and process improvement.
• Experience with GMP/cGMP manufacturing operations.
• Experience supporting deviations, CAPA, change control, and risk assessments.
• Strong troubleshooting and problem‑solving capabilities.
• Excellent communication and cross‑functional collaboration skills.