Project Manager III

Novozen Healthcare LLC

Tempe (AZ)

On-site

USD 85,000 - 92,000

Full time

4 hours ago
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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

  • Lead project engineering activities for complex cleanroom and capital projects from design development through construction, equipment integration, startup, commissioning, GMP turnover, and 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.
Required 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 a Total Installed Cost (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.
Preferred Qualifications
  • Professional Engineer (PE) license, PMP certification, or equivalent project leadership credential.
  • Direct experience with aseptic, biologics, medical device, or high-containment cleanroom projects.
  • Experience integrating automation, process equipment, commissioning, qualification, and validation activities.
  • Experience with stage-gate governance and large capital programs within operating manufacturing sites.
Pay Scale

Anticipated hourly pay range: $62/hr to $67/hr on W2.

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements.

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.

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