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Operational Readiness Technical Lead

3 weeks ago

Redmond, WA, United States Validation & Engineering Group Inc. Full time
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
  • 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.
Risk Management
  • 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
    • Status reports
    • 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.
  • Support continuous improvement across capital delivery processes.
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.
Qualifications & Experience

Required:
  • 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
    • Commissioning & Qualification (C&Q)
    • Utility systems
    • FDA and EMA regulatory frameworks
Preferred:
  • 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.
Key Competencies
  • Operational readiness leadership
  • Capital project execution
  • GMP and regulatory compliance
  • Risk management and issue resolution
  • Clear communication and documentation
  • Team leadership and knowledge transfer