Senior CQV Engineer - Second-Shift Validation Lead

Katalyst-Healthcares-; Tulsa (OK); In loco; USD 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

Creative Solutions Services, LLC is seeking an experienced CQV Lead for second shift to drive validation execution across pharmaceutical systems. You will coordinate daily priorities and interface with QA, Engineering, and Operations to resolve issues in real time.

Responsibilities include overseeing IQ/OQ protocols, equipment verification, temperature mapping, and support for SIP/CIP cycle development, while ensuring GMP/GDP compliant documentation and deviation management.

Competenze

• Bachelor's degree in STEM is required.
• 8+ years of CQV/validation experience in pharma or biotech.
• Hands-on experience with process equipment (bioreactors, filtration, chromatography, UF).
• Experience leading validation teams or shift-based execution.
• Strong GMP/GDP knowledge.
• Experience with eVal; ValGenesis a plus.

Mansioni

• Lead second shift CQV execution across multiple systems.
• Coordinate daily execution priorities to recover schedule slippage.
• Interface with QA, Engineering, and Operations to resolve issues.
• Oversee IQ/OQ protocols and operational verification activities.
• Drawing walkdowns and equipment verification.
• Materials of Construction (MOC) and weld verification.
• Temperature mapping and validation activities.
• Support SIP/CIP and related cycle development.
• Ensure GMP/GDP documentation is audit-ready.
• Drive deviation identification, escalation, and resolution.

Conoscenze

CQV execution

Validation leadership

GMP GDP knowledge

Cross-functional collaboration

Temperature mapping

Formazione

Bachelor's degree in STEM

Biomedical/Chemical Engineering preferred

Strumenti

eVal

ValGenesis

Ellab

Descrizione del lavoro

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.
• 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.
  

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).