LL01-260112 Operational Readiness Technical Lead & Capital Projects Manager

Validation & Engineering Group

Job Location:

Redmond, WA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Pinnaql is a trusted consulting partner to regulated life sciences companies providing deep technical validation and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical biotech and medical device organizations to navigate complexity accelerate project timelines and maintain a strong state of compliance and audit readiness.

We are currently seeking an Operational Readiness Technical Lead & Capital Projects Manager who 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:

Bachelors 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

Required Experience:

Manager

Pinnaql is a trusted consulting partner to regulated life sciences companies providing deep technical validation and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical biotech and medical device organizations to navigate complexity accelerate project timeli...