CQV and Quality Integration Lead

• 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.