Commissioning & Validation Specialist (C&Q/CSV)

Lancesoft; Wilson (NC); On-site; USD 90,000 - 125,000; Full time

Job summary

Lancesoft is seeking a Commissioning and Qualifications/CSV professional for an onsite role in Wilson, NC. You will review and approve IQ, OQ, PQ protocols and reports, and ensure regulatory compliance across GMP and FDA standards.

You will coordinate with QA, engineering and manufacturing to implement validated systems and documentation. The ideal candidate holds a Bachelor's in a scientific or engineering field and 2–4 years' validation experience in biotherapeutics/pharma, with strong

Qualifications

• Bachelor's degree in a scientific or engineering discipline is required.
• 2–4 years of biotherapeutic/pharmaceutical validation experience.
• Strong understanding of cGMP, FDA, EMA, ICH guidelines.

Responsibilities

• Review and approve commissioning/qualification documentation (URS, IQ, OQ, PQ).
• Provide QA oversight for C&Q/CSV activities to ensure GMP compliance.
• Support development and implementation of C&Q/validation plans and timelines.
• Perform QA reviews of system impact assessments and equipment categorization.
• Collaborate with engineering, validation, and manufacturing to address quality issues.

Skills

Validation experience

Fast-paced environment

Validation equipment experience

Education

Bachelor's degree in science or engineering

Tools

GAMP 5

ISPE Baseline Guides

Job description

Lancesoft is seeking a Commissioning and Qualifications/CSV professional for an onsite role in Wilson, NC. You will review and approve IQ, OQ, PQ protocols and reports, and ensure regulatory compliance across GMP and FDA standards.

You will coordinate with QA, engineering and manufacturing to implement validated systems and documentation. The ideal candidate holds a Bachelor's in a scientific or engineering field and 2–4 years' validation experience in biotherapeutics/pharma, with strong