LLOperational Readiness Technical Lead & Capital Projects Manager

Career Opportunities with Validation & Engineering Group

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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:

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.

• 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.
• 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.
• 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.
• 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
• Monitor and enforce compliance with cGMP, FDA, EMA, and applicable regulatory requirements.
• Coordinate with Quality Assurance and Regulatory Affairs to ensure inspection readiness.
• Ensure documentation supports regulatory submissions, audits, and inspections.
• Identify, assess, and proactively mitigate project risks.
• Maintain a comprehensive risk register with defined mitigation strategies.
• Escalate critical risks and issues in a timely and structured manner.
• Documentation & Reporting
• Maintain complete and compliant project documentation, including:
• Design reviews
• Meeting minutes
• Regulatory records
• Lead weekly project and team meetings with clear agendas and actionable follow-ups.
• Capital Projects Leadership Support
• Partner with Capital Projects leadership to plan, execute, and close out site initiatives.
• Ensure alignment with overall business, manufacturing, and operational strategy.
• Knowledge Transfer & Team Integration
• Provide mentorship, guidance, and training to project team members.
• Ensure effective knowledge transfer to operations and site teams.
• Support sustained operational readiness post-project handover.

• Bachelor’s degree in Engineering or a related technical discipline.
• Significant experience in GMP-regulated manufacturing environments (pharmaceutical, biotech, or medical device).
• Proven experience managing capital projects, facility expansions, or manufacturing startups.
• Strong working knowledge of:
• GMP regulations
• Utility systems
• FDA and EMA regulatory frameworks

• Experience supporting manufacturing expansion or startup projects (IPOD, JPOD, or similar).
• Strong cross-functional leadership and stakeholder management skills.
• Experience working with Quality, Regulatory, Engineering, and Operations teams.