Project Manager-Engineering

WuXi AppTec•Middletown, DE

About The Position

The Engineering Project Manager joins the DP Engineering team at the Middletown drug product facility and leads capital and engineering projects from scope definition and funding through design, procurement, installation, commissioning, qualification, turnover, and closeout. This individual-contributor role has no direct reports and provides project leadership for both client-driven and site-capability investments. The role manages project scope, schedule, budget, risk, vendors, and cross-functional execution, coordinating with Manufacturing, Technical Services, CQV, Automation/CSV, Facilities, Quality, EHS, Finance, Procurement, and external engineering and construction partners. It also supports site capital planning and maintains visibility into current and future capital needs across the drug product program.

Requirements

Bachelor's degree in Engineering or a related technical discipline.
7+ years of relevant engineering, capital-project, or pharmaceutical manufacturing experience, including demonstrated project leadership.
Experience managing capital projects through multiple lifecycle phases, such as concept/design, procurement, construction/installation, commissioning, qualification, turnover, and closeout.
Demonstrated ability to manage project scope, schedule, budget, risks, change control, vendors, and cross-functional stakeholders.
Working knowledge of pharmaceutical cGMP environments and the interfaces among Engineering, CQV, Quality, Manufacturing, Automation, Facilities, EHS, Finance, and Procurement.
Strong skills in project scheduling, cost tracking and forecasting, technical documentation, contract and vendor coordination, and executive communication.
Ability to manage multiple priorities and make sound decisions in a fast-paced start-up and operational environment.

Nice To Haves

Experience delivering oral solid dosage, sterile drug product, packaging, laboratory, or pharmaceutical facility capital projects.
Experience with greenfield start-up, major facility expansion, technology transfer, or client-driven capital programs.
Experience with SAP or similar ERP/WBS systems, Ariba or similar procurement platforms, and Microsoft Project or equivalent scheduling tools.
PMP certification or equivalent formal project-management training.
Experience managing A/E, general contractor, OEM, automation integrator, and CQV service-provider interfaces.
Familiarity with risk-based commissioning and qualification, change control, and GMP system turnover requirements.

Responsibilities

Lead project initiation, scope definition, business-case development, technical feasibility, cost estimating, schedule development, and execution planning for assigned capital projects.
Develop project charters, scope packages, milestones, resource plans, risk registers, and decision logs aligned with site priorities and approved funding.
Coordinate development of URS, design criteria, layouts, technical specifications, bid packages, and procurement strategies with functional SMEs and end users.
Ensure equipment, installation, utilities, automation/IT, CQV, EHS, tooling, spares, and related costs are captured in project forecasts and funding plans.
Own project baselines for scope, schedule, budget, commitments, actuals, forecast-to-complete, and estimate-at-completion.
Partner with Finance and Procurement to establish and maintain WBS and funding structures, purchase requisition and purchase order execution, commitments, cash flow, and financial closeout.
Manage project changes through documented scope, cost, schedule, risk, and approval processes, escalating material variances before additional commitments.
Prepare project status reports and executive updates covering progress, milestones, cost, risks, decisions, actions, and forecast completion.
Lead cross-functional execution through design review, vendor selection, FAT, site readiness, installation, SAT, commissioning, qualification, and operational turnover.
Manage OEMs, A/E firms, contractors, integrators, and service providers to defined scope, schedule, quality, safety, documentation, and commercial expectations.
Coordinate interfaces among manufacturing equipment, facilities and utilities, automation, containment, packaging, and site infrastructure to prevent execution gaps and late changes.
Drive resolution of technical issues, design changes, field conflicts, punch-list items, and vendor actions.
Ensure project execution aligns with applicable cGMP, Quality, EHS, permitting, and change-control requirements.
Coordinate with CQV and Quality so design, vendor documentation, commissioning records, and system turnover support an efficient qualification strategy.
Ensure project handover includes approved drawings, manuals, training, spare parts, asset information, maintenance and calibration requirements, qualification status, and ownership of open actions.
Support project closeout, lessons learned, financial settlement, and transition to Technical Services and Manufacturing ownership.
Serve as the primary project coordination point and facilitate timely decisions among sponsors, site leadership, Engineering, Operations, Quality, Finance, Procurement, and external partners.
Build and maintain integrated schedules and action trackers, identify critical-path risks, and implement recovery plans when milestones are threatened.
Communicate project issues transparently and provide recommendations balancing schedule, cost, technical risk, GMP compliance, and operational readiness.
Support the site capital planning process and maintain visibility into current and future capital needs across the drug product program.