- 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.
- 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.