CQV Lead: GMP-Ready Validation for Capital Projects

Inteldot; New Albany (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

Inteldot in New Albany, Ohio seeks a C&Q Lead to supervise commissioning, qualification, and validation activities for facilities, utilities, equipment, and systems. You will ensure regulatory compliance and align with quality standards while supporting capital project delivery and operational readiness.

You will lead cross-functional teams with Engineering, QA, Manufacturing and external vendors, manage risk assessments, review technical docs, and drive continuous improvement in validation

Qualifications

• Bachelor's degree in engineering, Life Sciences, or related field.
• 8+ years of CQV experience in pharmaceutical/biotechnology environment.
• Strong knowledge of GMP regulations and ISPE/ASTM E2500 standards.
• Experience with large-scale capital projects or facility start-ups.

Responsibilities

• Lead end-to-end commissioning and qualification activities for facilities, utilities, and systems.
• Develop and execute C&Q strategies, plans, and protocols (IQ/OQ/PQ).
• Collaborate with Engineering, QA, Manufacturing and external vendors.
• Ensure systems are designed, installed, tested and documented per GMP standards.
• Review and approve URS, FRS, design specs, and validation reports.
• Manage risk assessments (e.g., FMEA) to define qualification scope.
• Provide leadership and mentorship to C&Q engineers and contractors.
• Track timelines, budgets and deliverables to ensure on-time completion.
• Support regulatory inspections with C&Q documentation and SME input.
• Drive continuous improvement in validation processes and compliance.

Skills

Leadership

Regulatory compliance

GMP knowledge

Project management

Cross-functional collaboration

Education

Bachelor's degree in engineering, Life Sciences, or related field

Job description

Inteldot in New Albany, Ohio seeks a C&Q Lead to supervise commissioning, qualification, and validation activities for facilities, utilities, equipment, and systems. You will ensure regulatory compliance and align with quality standards while supporting capital project delivery and operational readiness.

You will lead cross-functional teams with Engineering, QA, Manufacturing and external vendors, manage risk assessments, review technical docs, and drive continuous improvement in validation