Junior Validation Engineer (GMP/Biotech) – Hybrid

PSC Biotech® Corporation; Minneapolis (MN); Hybrid; USD 70.000 - 110.000; Vollzeit

Benefits dieser Stelle

Health premiums covered

401(k) matching

Paid time off

Education assistance

Pet insurance

Zusammenfassung

PSC Biotech® Corporation in Minneapolis is seeking Junior Validation Engineers to support pharmaceutical manufacturing projects, covering facility, utility, equipment, automation, and process validation in GMP environments.

You will contribute to protocol development, field execution, discrepancy resolution, and documentation while collaborating with engineering, quality, manufacturing, automation, and project teams. Entry-level to senior roles available, with growth opportunities.

Qualifikationen

• Bachelor's degree in engineering or related technical field.
• Experience in biopharmaceutical facilities and GMP environments.
• Experience with Kneat Gx validation platform is required.
• Experience with commissioning, qualification, and validation activities across facilities, utilities, equipment, and systems.

Aufgaben

• 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 and documentation 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 on deliverables.
• Assist with turnover, startup, and operational readiness activities.
• Follow GDP, approved procedures, validation strategies, and SOPs; support investigations and CAPA activities.

Kenntnisse

Hybrid work experience

Ausbildung

Bachelor's degree in Engineering / Biotechnology / Chemistry / Pharmaceutical Sciences

Tools

Kneat Gx

MES

SCADA

PLC

Jobbeschreibung

PSC Biotech® Corporation in Minneapolis is seeking Junior Validation Engineers to support pharmaceutical manufacturing projects, covering facility, utility, equipment, automation, and process validation in GMP environments.

You will contribute to protocol development, field execution, discrepancy resolution, and documentation while collaborating with engineering, quality, manufacturing, automation, and project teams. Entry-level to senior roles available, with growth opportunities.