Lead CQV Engineer

Creative Solutions Services, LLC; Memphis (TN); On-site; USD 110,000 - 170,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Lead CQV validation professional to drive second-shift CQV execution across multiple systems in pharma/biotech. You will coordinate between QA, Engineering and Operations to maintain timelines and resolve issues in real time.

The role requires a STEM bachelor’s, 8+ years CQV/validation, hands-on equipment experience (bioreactors, filtration, chromatography, UF), and GMP/GDP knowledge; experience with eVal, ValGenesis, and Ellab is a plus.

Qualifications

• Bachelor's degree or equivalent in a STEM field; Biomedical/Chemical Engineering preferred.
• 8+ years CQV/validation experience in pharma or biotech.
• Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF).
• Proven experience leading validation teams or shift-based execution efforts.
• Strong GMP/GDP knowledge.

Responsibilities

• Lead second shift CQV execution across multiple systems and workstreams.
• Coordinate daily execution priorities to recover schedule slippage and maintain timelines.
• Interface with QA, Engineering, and Operations to resolve issues in real time.
• Oversee IQ/OQ protocols and operational verification activities.
• Drive deviation identification, escalation, and resolution.
• Ensure all documentation meets GMP/GDP and audit-ready standards.
• Support SIP/CIP and related cycle development activities as needed.

Skills

CQV validation

GMP/GDP knowledge

Shift leadership

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree (STEM preferred)

Tools

eVal

ValGenesis

Ellab

Temperature mapping

Job description

Job Description

• Lead second shift CQV execution activities across multiple systems and workstreams.
• Coordinate daily execution priorities to recover schedule slippage and maintain timelines.
• Interface with QA, Engineering, and Operations to resolve issues in real time.
• Oversee execution of IQ/OQ protocols and operational verification activities.

Requirements

• Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred).
• 8+ years of CQV/validation experience in pharma or biotech.
• Strong hands‑on execution background with process equipment (bioreactors, filtration, chromatography, UF).
• Proven experience leading validation teams or shift‑based execution efforts.
• Strong GMP/GDP knowledge.
• Experience with eVal (required), ValGenesis a plus.
• Experience with temperature mapping (Ellab a plus).
• This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends.

Support and review

• 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.