CQV Engineer - Validation & Commissioning Specialist Hybrid

PSC 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 and biotechnology manufacturing projects, including facility, utility, equipment, automation, and process validation activities in GMP environments.

Successful candidates will contribute to protocol development, field execution, and documentation while collaborating with engineering, quality, manufacturing, automation, and project teams.

Qualifications

• Bachelor's degree in Engineering, Biotechnology, Biology, Chemistry, Pharmaceutical Sciences, or related technical discipline.
• Experience in biopharmaceutical, cell culture, biologics, vaccine, or sterile manufacturing facilities.
• Experience with Kneat Gx (digital validation platform).
• Experience with Facility/Utility/Equipment/Automation Qualification, Cleaning Validation, or CSV processes.
• Familiarity with MES/SCADA/PLC systems and data integrity programs.

Responsibilities

• Author, review, execute, and close commissioning, qualification, and validation protocols and reports.
• Support installation, operational, and performance verification activities for facilities and systems.
• Perform field testing and document results per quality standards; assist with data analysis and reports.
• Maintain traceability between requirements, risk assessments, testing activities, and validation deliverables.
• Coordinate with engineers, QA, automation, and project teams to support execution and turnover.

Skills

Kneat Gx

GMP Validation

Project coordination

Education

Bachelor's degree in Engineering

Tools

MES

SCADA

PLC

CSV

Job description

PSC Biotech is seeking CQV and Validation Engineers at multiple experience levels to support pharmaceutical and biotechnology manufacturing projects, including facility, utility, equipment, automation, and process validation activities in GMP environments.

Successful candidates will contribute to protocol development, field execution, and documentation while collaborating with engineering, quality, manufacturing, automation, and project teams.