Senior CQV & CSV Engineer — Validation Leader

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

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.