CQV and Quality Integration Lead

Advanced Manufacturing Tech Solutions (AMTSOL); Arizona; On-site; USD 130,000 - 210,000; Full time

Job summary

AMTSOL (Advanced Manufacturing Tech Solutions) seeks an experienced CQV lead to drive integrated commissioning, qualification and validation on a regulated capital project in the Phoenix area. This role requires senior expertise in GMP, CQV strategies and turnover readiness.

The ideal candidate will manage risk assessments, establish traceability and coordinate across design, commissioning and turnover activities to ensure compliant project delivery.

Qualifications

• Bachelor’s degree in Engineering, Science, Pharmaceutical Technology or related discipline.
• 8+ years in commissioning, qualification, validation, quality engineering or GMP project delivery, including leading system turnover and readiness.
• Documented experience on construction projects with TIC above $30M (evidenced on CV).
• Risk-based CQV, requirements traceability, design qualification, deviation management and data integrity.
• Current GMP, data-integrity and document-control training.

Responsibilities

• Develop the integrated CQV and quality execution strategy.
• Define system boundaries, ownership, turnover pathways and release dependencies.
• Coordinate GMP impact assessments, quality risk assessments and requirements traceability.
• Align design reviews with commissioning, qualification, validation and turnover needs.
• Define readiness criteria for mechanical completion, commissioning, qualification and handover.
• Track quality actions, deviations and prerequisite closure.
• Manage turnover-package content, indexing, review and acceptance.

Skills

CQV leadership

GMP knowledge

Quality risk

Requirements traceability

Document control

Education

Bachelor's degree in Engineering

Pharma/Life Sciences background

Job description

• Location Phoenix Metro, Arizona, USA (onsite)
• Engagement Long-term contract, through 2028 (subject to project phase)
• Experience 8+ years
• Start ASAP

About AMTSOL

AMTSOL (Advanced Manufacturing Tech Solutions Pte. Ltd.) is a technology and engineering consulting company that specializes in Life Sciences Manufacturing, with a primary focus on Pharma 4.0 and digitalization.

Role Overview

Lead integrated commissioning, qualification and validation (CQV), GMP review, quality risk and turnover coordination for a regulated capital project.

Key Responsibilities

• Develop the integrated CQV and quality execution strategy.
• Define system boundaries, ownership, turnover pathways and release dependencies.
• Coordinate GMP impact assessments, quality risk assessments and requirements traceability.
• Align design reviews with commissioning, qualification, validation and turnover needs.
• Define readiness criteria for mechanical completion, commissioning, qualification and handover.
• Track quality actions, deviations and prerequisite closure.
• Manage turnover-package content, indexing, review and acceptance.

Requirements

• Bachelor’s degree in Engineering, Science, Pharmaceutical Technology or related discipline.
• 8+ years in commissioning, qualification, validation, quality engineering or GMP project delivery, including leading system turnover and readiness.
• Documented experience on construction projects with a total installed cost (TIC) above $30M (required, must be evidenced on the CV).
• Risk-based CQV, requirements traceability, design qualification, deviation management and data integrity.

Licences and Certifications

• Current GMP, data-integrity and document-control training.