Validation Engineer (CQV/CSV)

Des Moines, IA, US • Posted 3 hours ago • Updated 30 minutes ago

Full Time

Part Time

On-site

Fitment

Dice Job Match Score™

👾 Reticulating splines...

Job Details

Skills

GMP
Documentation
Computerized System Validation
Life Sciences
IQ
OQ
PQ
Manufacturing
Chromatography
Good Manufacturing Practice
Regulatory Compliance
SANS
Traceability Matrix

Summary

Overview:

Seeking a Biopharmaceutical Validation Engineer to support commissioning, qualification, and validation (CQV) activities for GMP manufacturing equipment and integrated systems. The role requires a self-driven professional capable of authoring and executing validation documentation independently while ensuring compliance with cGMP standards and regulatory requirements.

Key Responsibilities:

Author, review, and execute commissioning and qualification protocols (IQ/OQ/PQ) for single-use and multi-use manufacturing equipment.
Support synchronization of manufacturing equipment and automated systems to ensure compliant operations.

Develop and maintain validation documentation in alignment with site SOPs and regulatory standards.
Apply risk-based validation methodologies to streamline qualification activities while maintaining quality and compliance.

Required Experience:

4+ years of CQV and CSV experience within Life Sciences / Biopharmaceutical industry
Hands-on experience authoring and executing IQ/OQ/PQ protocols
Strong knowledge of biologics manufacturing equipment (TFF, Chromatography, Bioreactors)
Experience with cGMP environments and 21 CFR Part 11 compliance
Experience developing Validation Summary Reports, Deviation Reports, and Traceability Matrices

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 90737436
Position Id: OOJ - 8101-7105-1773408988
Posted 3 hours ago

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