- 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.