Role summary
Provides senior project engineering leadership for complex cleanroom and capital-project scope from design development through construction, equipment integration, startup, commissioning, GMP turnover, and closeout. The role integrates multidisciplinary technical work, establishes clear scope and interface ownership, and drives timely resolution of risks, decisions, and execution barriers. It contributes to safe, compliant, coordinated delivery of Project Fire and the B475 Cleanroom program.
Key responsibilities
- Lead development and maintenance of the project execution plan for assigned scope, including governance of scope, cost, schedule, safety, quality, risk, and change.
- Define and maintain scope boundaries, battery limits, tie-in points, work-package ownership, and Owner/designer/contractor/vendor responsibility and interface matrices.
- Coordinate architectural, process, mechanical, electrical, automation, controls, life-safety, cleanroom, equipment, and utility interfaces.
- Plan and facilitate formal design reviews at required maturity gates, assessing completeness, constructability, operability, maintainability, installation readiness, commissioning readiness, and equipment integration.
- Drive documented disposition and closure of design comments, technical issues, scope gaps, overlaps, conflicts, late decisions, risks, actions, and changes.
- Establish equipment interface requirements, utility loads, connection points, controls interfaces, access and maintenance clearances, vendor-data needs, and installation sequence.
- Identify long-lead equipment decisions, vendor dependencies, and schedule constraints and escalate impacts with mitigation options.
- Provide technical support during construction, coordinate responses to RFIs and field conflicts, and participate in walkdowns and deficiency resolution.
- Integrate mechanical completion, commissioning, startup, qualification support, GMP turnover, and operational handover planning.
- Prepare and transfer complete project engineering records and a final closeout report identifying residual items, risks, owners, and target disposition dates.
What success looks like
- Approved execution plan, responsibility/interface matrix, and scope/battery-limit matrix are established early and kept current.
- Formal design reviews occur at required maturity stages, with no unresolved material item preventing the next approved stage.
- Equipment utility, access, installation, and controls interfaces are documented and coordinated before field execution.
- Installation, energization, commissioning, startup, and turnover prerequisites have accountable owners and forecast dates.
- Mechanical-completion and turnover boundaries are agreed, records are complete, and residual items are formally transferred at closeout.
Required qualifications
| Education, training, or equivalent experience |
Bachelor's degree in engineering or a closely related technical discipline, or an equivalent combination of education and progressively responsible project engineering experience. |
| Relevant experience |
Typically 10+ years in capital project engineering, including leadership of multidisciplinary design, construction, commissioning, and turnover on complex projects. Documented experience on construction projects with total installed cost exceeding $30 million is required. Regulated pharmaceutical, biotechnology, medical-device, or similarly controlled manufacturing experience is required. |
| Required skills or knowledge |
Advanced scope and interface management; multidisciplinary design integration; cleanroom and utility coordination; risk, issue, action, decision, and change control; constructability and readiness reviews; equipment integration; technical writing; executive communication; and practical knowledge of GMP project delivery and turnover. |
| Required licenses or certifications, if applicable |
No license is universally required. A Professional Engineer license is required only when the assigned duties include responsible charge or sealed engineering work. Current site-required safety and GMP training must be completed before performing applicable work. |
Preferred qualifications
- Professional Engineer license, PMP certification, or equivalent project leadership credential.
- Direct experience with aseptic, biologics, 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 in an operating manufacturing site.
Key working relationships
- Project Engineering and project leadership, for scope, governance, decisions, and escalation.
- Design firms and discipline engineers, for multidisciplinary coordination and design maturity.
- Construction management, contractors, and trade partners, for field execution and issue resolution.
- Operations, Facilities, Maintenance, Engineering, Automation, Quality, Validation, CQV, EHS, Procurement, and project controls, for readiness and integrated delivery.
- Equipment and system vendors, for technical data, interfaces, installation, testing, and startup support.
Working conditions or role requirements
- Substantial onsite presence during critical installation, commissioning, startup, and turnover activities.
- Work in active construction and regulated manufacturing environments, requiring PPE, site orientation, and compliance with access and work-control requirements.
- Schedule flexibility may be required for shutdowns, tie-ins, energizations, critical tests, and recovery activities.
- Occasional travel may be required for vendor visits, factory acceptance testing, or design coordination.
Additional information
- This is a senior integration role. It coordinates but does not independently approve changes to GMP requirements, project funding, contractual commitments, or Owner policy.
- Detailed design, construction means and methods, and validation protocol authorship or execution remain with the responsible parties unless specifically assigned.
Role complexity note: Senior leadership role with broad field and cross-functional accountability across multiple project phases and workstreams.
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Spectraforce Technologies
Nov 03, 2026