Senior CQV Validation Specialist – GMP Biomanufacturing

SRG; Rochester (MN); On-site; USD 120,000 - 180,000; Full time

Job summary

Impellam Group's CQV Specialist role in Minnesota is a fully onsite, 12-month engagement supporting commissioning, qualification, and validation across upstream and fill-finish systems in a GMP biomanufacturing environment.

The candidate will author and execute IQ/OQ/PQ protocols, manage deviations and CAPA, and collaborate with Engineering, Manufacturing, and Quality teams to ensure regulatory compliance and audit readiness.

Qualifications

• 10+ years of CQV/Validation experience in pharma/biotech.
• Experience authoring and executing IQ/OQ/PQ protocols.
• Strong GMP knowledge and FDA/cGMP familiarity.

Responsibilities

• Author, review, and execute IQ/OQ/PQ protocols and validation reports.
• Manage deviations, investigations, and CAPA at CQV projects.
• Support commissioning and qualification of manufacturing equipment and systems.
• Collaborate with Engineering, Manufacturing, Quality, and Validation teams.

Skills

CQV & Validation

Technical writing

Regulatory compliance GMP

Deviation management

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related

Job description

Impellam Group's CQV Specialist role in Minnesota is a fully onsite, 12-month engagement supporting commissioning, qualification, and validation across upstream and fill-finish systems in a GMP biomanufacturing environment.

The candidate will author and execute IQ/OQ/PQ protocols, manage deviations and CAPA, and collaborate with Engineering, Manufacturing, and Quality teams to ensure regulatory compliance and audit readiness.