CQV Engineer – Pharma Validation & Commissioning

biotech; Minneapolis (MN); Hybrid; USD 90,000 - 130,000; Full time

Job summary

PSC Biotech is seeking CQV and Validation Engineers at multiple experience levels to support pharmaceutical manufacturing projects within GMP environments. Responsibilities include commissioning, qualification, and validation activities across facilities, utilities, equipment, automation, and process systems.

You'll work with engineering, quality, manufacturing, and automation teams, with onsite support during commissioning and startup in a hybrid work setting.

Qualifications

• Bachelor's degree in Engineering, Biotechnology, Biology, Chemistry, Pharmaceutical Sciences, or a related technical discipline.
• Experience in biopharmaceutical, cell culture, biologics, vaccine, or sterile manufacturing facilities.
• Experience with Kneat Gx or similar validation platforms.

Responsibilities

• Author, review, execute, and close commissioning, qualification, and validation protocols and reports.
• Support installation, operational, and performance verification activities for facilities, utilities, equipment, and manufacturing systems.
• Execute field testing and document results in compliance with quality standards.
• Assist with protocol revisions, data analysis, and final report generation.
• Maintain traceability between requirements, risk assessments, testing activities, and validation deliverables.
• Coordinate with project engineers, manufacturing personnel, quality representatives, and vendors during project execution.

Skills

Project coordination

Quality compliance

Documentation

Cross-functional collaboration

Education

Bachelor's degree

Tools

Kneat Gx

MES

SCADA

PLC systems

Job description

PSC Biotech is seeking CQV and Validation Engineers at multiple experience levels to support pharmaceutical manufacturing projects within GMP environments. Responsibilities include commissioning, qualification, and validation activities across facilities, utilities, equipment, automation, and process systems.

You'll work with engineering, quality, manufacturing, and automation teams, with onsite support during commissioning and startup in a hybrid work setting.