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Validation & Engineering Group, Inc. · 1 day ago

LL01-260112 Operational Readiness Technical Lead & Capital Projects Manager

Redmond, WA

Full-time

Onsite

Senior Level

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries including Pharmaceutical and Biotechnology. They are seeking an Operational Readiness Technical Lead & Capital Projects Manager to lead a Manufacturing Expansion Project, ensuring readiness for GMP operations and regulatory compliance while coordinating with stakeholders and cross-functional teams.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

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

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

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

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

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

Qualification

GMP regulationsCommissioning & Qualification (C&Q)Utility systemsCapital project executionRegulatory complianceRisk managementKnowledge transferTeam leadershipClear communication