LL01-260112 Operational Readiness Technical Lead & Capital Projects Manager

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Operational Readiness Technical Lead & Capital Projects Manager

The Operational Readiness Technical Lead & Capital Projects Manager will lead a Manufacturing Expansion Project, drive increased manufacturing capacity and ensuring end-to-end readiness for GMP operations. This role is critical to expanding production capacity while maintaining full regulatory compliance and effective coordination with internal stakeholders, suppliers, and cross-functional teams.

The position provides technical leadership across project planning, design oversight, utilities integration, Commissioning & Qualification (C&Q), regulatory compliance, and operational readiness, applying lessons learned at startups to enable scalable, compliant manufacturing expansion.

Key Responsibilities

Project Planning & Coordination

• Develop, maintain, and execute a comprehensive project plan covering all phases from design through Commissioning & Qualification (C&Q).

• Define and manage milestones, schedules, dependencies, and deliverables.

• Communicate project status, risks, and progress clearly to all stakeholders.

Design & Engineering Oversight

• Ensure all design packages meet GMP requirements and align with operational readiness objectives.

• Apply lessons learned from previous startups to improve design efficiency and scalability.

• Support future expansion planning through robust, compliant design solutions.

Utilities Installation & Integration

• Support installation and integration of critical utility systems.

• Ensure utilities are designed, installed, and commissioned in compliance with GMP and regulatory standards.

• Coordinate closely with engineering, construction, and vendors during execution.

Commissioning & Qualification (C&Q) Readiness

• Support development and execution of detailed C&Q plans for facilities, utilities, and manufacturing systems.

• Ensure systems are validated, documented, and ready for operational use.

• Align C&Q activities with quality and regulatory expectations.

Regulatory & GMP Compliance