Senior CQV Process Engineer - Validation & Manufacturing

Pinnaql, Inc.; United States; On-site; USD 100,000 - 150,000; Full time

Job summary

Validation & Engineering Group in the United States is seeking a Senior Process Engineer CQV Validation Engineer to lead IQ/OQ/PQ activities and drive manufacturing readiness. You will collaborate with Manufacturing Operations, Engineering, Maintenance and Quality to execute validation, perform data analysis, and support CAPAs and change controls, ensuring regulatory compliance and robust processes.

This role is primarily on site with limited remote work, focusing on GMP documentation, protocol

Qualifications

• Minimum 5 years of experience in Process Engineering, Validation, CQV or related.
• Experience with IQ/OQ/PQ protocols and GMP/regulated documentation practices.
• Strong writing, analysis and problem-solving skills.

Responsibilities

• Lead IQ/OQ/PQ protocols and commissioning activities.
• Perform process characterization and capability assessments.
• Support equipment qualification and system verification.
• Collaborate with Manufacturing Operations, Engineering, Maintenance and Quality teams.
• Develop validation summaries, reports and final deliverables.

Skills

Process engineering

Data analysis

Technical writing

Troubleshooting

Job description

Validation & Engineering Group in the United States is seeking a Senior Process Engineer CQV Validation Engineer to lead IQ/OQ/PQ activities and drive manufacturing readiness. You will collaborate with Manufacturing Operations, Engineering, Maintenance and Quality to execute validation, perform data analysis, and support CAPAs and change controls, ensuring regulatory compliance and robust processes.

This role is primarily on site with limited remote work, focusing on GMP documentation, protocol