CQV Specialist
Location: Minnesota
Onsite Requirement: Fully onsite
Contract Length: 12 months plus extensions

*We CANNOT except C2C/Visa candidates at this time.

Job Summary
We are seeking an experienced CQV Specialist to support commissioning, qualification, and validation activities within a large-scale GMP biomanufacturing environment. This individual will play a key role in ensuring manufacturing equipment and systems are properly qualified, documented, and compliant with regulatory requirements. The CQV Specialist will author and execute validation protocols, manage deviations, support investigations, and drive qualification activities across upstream and fill-finish manufacturing systems.

CQV / Validation Support

• Author, review, and execute IQ/OQ/PQ protocols and validation reports.
• Develop, revise, and execute qualification documentation in accordance with GMP requirements.
• Support commissioning, startup, and qualification activities for manufacturing equipment and systems.

Deviation & Compliance Management

• Write, investigate, and resolve deviations related to CQV activities.
• Support root cause investigations and CAPA implementation.
• Ensure documentation complies with GMP, GDP, and site quality standards.

Manufacturing Equipment Support
Provide CQV support for:

• Upstream vessels and bioreactors
• Fill-finish manufacturing lines
• Transfer panels and process transfer systems
• CIP/SIP systems and process utilities

Cross-Functional Support

• Collaborate with Engineering, Manufacturing, Quality, and Validation teams.
• Support risk assessments, change controls, and project documentation.
• Assist with regulatory inspection and audit readiness activities.

Required Experience

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.
• 10+ years of CQV, Validation, Quality, or Engineering experience within the pharmaceutical, biotechnology, or life sciences industry.
• Experience authoring and executing IQ/OQ/PQ protocols.
• Experience writing and managing deviations within a GMP-regulated environment.
• Working knowledge of FDA, cGMP, and validation requirements.
• Strong technical writing and documentation skills.
• Strong verbal and written communication skills.

Why This Role

• Large-scale biomanufacturing environment spanning upstream and fill-finish operations.
• High-visibility project with direct exposure to commissioning/qualification of major manufacturing systems.
• Cross-functional collaboration with Engineering, Manufacturing, and Quality leadership.
• 12-month engagement with strong potential for extension based on project scope.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.