CQV Engineer (All Levels) – Validation & Commissioning

PSC Biotech® Corporation; Minneapolis (MN); Híbrido; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

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

You will contribute to protocol development, field execution, data analysis, and final reporting while collaborating with engineering, quality, manufacturing, automation, and project teams.

Formación

• Bachelor's degree in Engineering, Biotechnology, Biology, Chemistry, Pharmaceutical Sciences, or related.
• Experience in biopharmaceutical manufacturing facilities (cell culture, biologics, sterile).
• Experience with Kneat Gx validation platform.

Responsabilidades

• 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 per 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, automation engineers, and vendors.
• Support project schedules, execution plans, and commissioning readiness activities.
• Participate in project meetings and provide status updates.
• Assist with turnover, startup, and operational readiness activities.
• Follow GDP, SOPs, validation strategies; support investigations and deviations.

Educación

Bachelor's degree in Engineering or related technical discipline

Herramientas

Kneat Gx

MES/SCADA/PLC systems

Descripción del empleo

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

You will contribute to protocol development, field execution, data analysis, and final reporting while collaborating with engineering, quality, manufacturing, automation, and project teams.