Senior CQV / CSV Engineer

Staftonic LLC; Minnesota; On-site; USD 90,000 - 120,000; Full time

Job summary

A life sciences consulting firm in Minnesota is looking for a highly experienced professional to lead lifecycle Commissioning and Qualification (CQV) activities. Candidates should have a minimum of 6 years of experience in CQV and/or CSV, particularly with GMP-regulated manufacturing systems. The role involves authoring validation protocols, collaborating with engineering teams, and ensuring compliance with industry standards. Strong technical writing and the ability to work independently are crucial for success in this fast-paced environment.

Qualifications

• Minimum 6+ years of experience in CQV and/or CSV within the life sciences industry.
• Hands-on experience with validation of biologics manufacturing systems.
• Experience with deviation management and regulatory audit readiness.

Responsibilities

• Lead lifecycle Commissioning and Qualification (CQV) activities.
• Author, review, and execute validation protocols and reports.
• Collaborate with automation and engineering teams.

Skills

CQV and/or CSV experience

Executing IQ/OQ/PQ for GMP-regulated equipment

Technical writing and documentation skills

Job description

• Lead lifecycle Commissioning and Qualification (CQV) activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Author, review, and execute validation protocols and reports for multi-use and single-use manufacturing systems.
• Develop and maintain key validation documents, including:
• Risk Assessments (FMEA / Risk-Based Validation)
• Traceability Matrices (RTM)
• Validation Summary Reports (VSR)
• Deviation Reports and CAPAs
• Collaborate with automation and engineering teams to ensure synchronization between physical equipment and automated control systems.
• Support validation of integrated GMP systems, including automation platforms and electronic documentation systems.
• Apply risk-based validation approaches in alignment with ASTM E2500 principles.
• Ensure compliance with 21 CFR Part 11, Data Integrity (ALCOA+), GAMP 5, and current industry best practices.
• Drive validation activities independently in a fast-paced manufacturing environment.

Required Qualifications

• Minimum 6+ years of CQV and/or CSV experience within the life sciences industry.
• Strong hands-on experience executing IQ/OQ/PQ for GMP-regulated manufacturing equipment.
• Proven experience validating biologics manufacturing systems such as:
• Bioreactors
• TFF (Tangential Flow Filtration) systems
• Chromatography systems
• CIP/SIP systems
• Filtration skids
• Experience with deviation management and regulatory audit readiness.
• Strong technical writing and documentation skills.
• Ability to work independently with minimal oversight.