Senior Project Manager, GMP Cleanroom Capital Projects

Novozen Healthcare LLC; Tempe (AZ); On-site; USD 85,000 - 92,000; Full time

Benefits offered by this job

Health Insurance

Retirement Benefits

PTO per state/local law

Job summary

Novozen Healthcare LLC is seeking a Lead Project Engineer to drive complex cleanroom and capital projects from design development through construction, startup, commissioning, GMP turnover, and closeout. The role requires leadership across multidisciplinary teams and hands-on coordination of interfaces and change management.

The incumbent will develop execution plans, manage scope and risks, and ensure readiness for turnover, leveraging 10+ years in capital project engineering within regulated

Qualifications

• Bachelor's degree in Engineering or a closely related technical discipline, or equivalent education and progressively responsible project engineering experience.
• 10+ years of capital project engineering experience, including leadership of multidisciplinary design, construction, commissioning, and turnover activities.
• Documented experience managing construction projects with TIC exceeding $30 million.
• Experience in regulated pharmaceutical, biotechnology, medical device, or similarly controlled manufacturing environments.
• Strong expertise in scope and interface management, multidisciplinary design integration, cleanroom and utility coordination, and equipment integration.
• Experience with risk, issue, action, decision, and change management.
• Knowledge of constructability reviews, project readiness assessments, GMP project delivery, and turnover requirements.
• Strong technical writing, communication, and stakeholder-management skills.

Responsibilities

• Lead project engineering activities for complex cleanroom and capital projects from design through closeout.
• Develop and maintain project execution plans covering scope, cost, schedule, safety, quality, risk, and change management.
• Define project scope boundaries, battery limits, tie-in points, work-package ownership, and responsibility matrices.
• Coordinate multidisciplinary interfaces across architectural, process, mechanical, electrical, automation, controls, life-safety, cleanroom, equipment, and utility teams.
• Lead formal design reviews to assess design maturity, constructability, operability, maintainability, installation readiness, and commissioning readiness.
• Drive resolution of design comments, technical issues, scope gaps, risks, conflicts, and project changes.
• Establish equipment interface requirements, utility loads, connection points, controls interfaces, access clearances, and installation sequences.
• Identify long-lead equipment requirements, vendor dependencies, and schedule constraints, and develop mitigation strategies.
• Provide technical support during construction, coordinate RFI responses, participate in field walkdowns, and resolve deficiencies.
• Integrate mechanical completion, commissioning, startup, qualification support, GMP turnover, and operational handover activities.
• Maintain project engineering records and prepare final closeout reports documenting residual items, risks, owners, and disposition timelines.

Skills

Leadership

Technical writing

Stakeholder management

Risk/change management

Education

Bachelor's degree in Engineering or related field

Professional Engineer (PE) license

PMP certification

Job description

Novozen Healthcare LLC is seeking a Lead Project Engineer to drive complex cleanroom and capital projects from design development through construction, startup, commissioning, GMP turnover, and closeout. The role requires leadership across multidisciplinary teams and hands-on coordination of interfaces and change management.

The incumbent will develop execution plans, manage scope and risks, and ensure readiness for turnover, leveraging 10+ years in capital project engineering within regulated