CQV Validation Lead - Second Shift (IQ/OQ)

Katalyst CRO; Concord (NH); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO seeks a CQV/validation expert for second shift in a pharma/biotech environment. Lead CQV execution across multiple systems, coordinate priorities to recover schedule slippage, and interface with QA, Engineering, and Operations to resolve issues in real time.

Must have 8+ years of CQV/validation experience, strong GMP/GDP knowledge, and hands-on experience with bioprocess equipment. Second shift (2-10 PM EST) and weekend work required.

Qualifications

• Bachelor's degree required; STEM preferred.
• 8+ years CQV/validation experience in pharma/biotech.
• Strong hands-on execution background with process equipment.

Responsibilities

• Drawing walkdowns.
• Equipment and component verification.
• Materials of Construction (MOC) and weld verification.
• Provide oversight for temperature mapping and validation activities.
• Support SIP/CIP and related cycle development activities as needed.
• Ensure all documentation meets GMP/GDP and audit-ready standards.
• Drive deviation identification, escalation, and resolution.

Skills

CQV/validation

GMP/GDP knowledge

Leadership

Documentation

Deviation management

Regulatory compliance

Equipment validation

Education

Bachelor's Degree in STEM

Tools

eVal

ValGenesis

Ellab

Job description

Katalyst CRO seeks a CQV/validation expert for second shift in a pharma/biotech environment. Lead CQV execution across multiple systems, coordinate priorities to recover schedule slippage, and interface with QA, Engineering, and Operations to resolve issues in real time.

Must have 8+ years of CQV/validation experience, strong GMP/GDP knowledge, and hands-on experience with bioprocess equipment. Second shift (2-10 PM EST) and weekend work required.