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:

• 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