C&Q Lead (Commissioning & Qualification Lead)

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

Role Summary

The C&Q Lead is responsible for overseeing and executing commissioning, qualification, and validation (CQV) activities for manufacturing facilities, utilities, equipment, and systems. This role ensures compliance with regulatory requirements and internal quality standards while supporting the successful delivery of capital projects and operational readiness.

Full-time onsite presence in New Albany, Ohio.

Key Responsibilities

• Lead end-to-end commissioning and qualification activities for new and existing systems, including facilities, utilities, and process equipment
• Develop and execute C&Q strategies, plans, and protocols (IQ/OQ/PQ) aligned with regulatory expectations (e.g., FDA, EMA)
• Collaborate cross-functionally with Engineering, Quality Assurance, Manufacturing, and external vendors
• Ensure systems are designed, installed, tested, and documented in compliance with GMP standards
• Review and approve technical documentation including URS, FRS, design specs, and validation reports
• Manage risk assessments (e.g., FMEA, impact assessments) to determine qualification scope
• Provide leadership and mentorship to C&Q engineers and contractors
• Track project timelines, budgets, and deliverables to ensure on-time project completion
• Support regulatory inspections and audits by providing C&Q documentation and SME expertise
• Drive continuous improvement initiatives related to validation processes and compliance

General Qualifications

• Bachelor's degree in engineering, Life Sciences, or related field
• 8+ years of experience in commissioning, qualification, and validation within the pharmaceutical or biotechnology industry
• Strong knowledge of GMP regulations and industry standards (e.g., ISPE, ASTM E2500)
• Experience with large-scale capital projects or facility start-upsDemonstrated leadership experience managing teams or projects