Project Manager-Engineering

Overview

We are seeking an Engineering Project Manager to join the DP Engineering team at the Middletown drug product facility. The Project Manager will lead capital and engineering projects from scope definition and funding through design, procurement, installation, commissioning, qualification, turnover, and closeout.

The role will manage project scope, schedule, budget, risk, vendors, and cross-functional execution while coordinating closely with Manufacturing, Technical Services, CQV, Automation/CSV, Facilities, Quality, EHS, Finance, Procurement, and external engineering/construction partners. This is an individual-contributor role with no direct reports and is expected to provide disciplined project leadership across both client-driven and site-capability investments.

Responsibilities

Project Development and Planning

• Lead project initiation, scope definition, business-case development, technical feasibility, cost estimating, schedule development, and execution planning for assigned capital projects.
• Develop clear 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 foreseeable equipment, installation, utilities, automation/IT, CQV, EHS, tooling, spares, and related project costs are captured in the project forecast and funding plan.

CAPEX / Cost / Schedule Control

• Own the project baseline for scope, schedule, budget, commitments, actuals, forecast-to-complete, and estimate-at-completion for assigned projects.
• Partner with Finance and Procurement to establish and maintain WBS/funding structures, PR/PO execution, commitments, cash flow, and financial closeout.
• Manage project changes through documented scope, cost, schedule, risk, and approval processes and escalate material variances before additional commitment.
• Prepare concise project status reports and executive updates covering progress, milestones, cost, risks, decisions, actions, and forecast completion.

Engineering and Vendor Execution

• Lead cross-functional project 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/utilities, automation, containment, packaging, and site infrastructure to prevent execution gaps and late changes.
• Drive timely resolution of technical issues, design changes, field conflicts, punch-list items, and vendor actions.

GMP, Safety, and Turnover

• 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/calibration requirements, qualification status, and open-action ownership.
• Support project closeout, lessons learned, financial settlement, and transition to Technical Services and Manufacturing ownership.

Stakeholder Leadership

• Serve as the primary project coordination point for assigned projects and facilitate timely decisions among sponsors, site leadership, Engineering, Operations, Quality, Finance, Procurement, and external partners.
• Build and maintain integrated schedules and action trackers, proactively identify critical-path risks, and implement recovery plans when milestones are threatened.
• Communicate project issues transparently and provide practical recommendations that balance schedule, cost, technical risk, GMP compliance, and operational readiness.
• Support the site capital planning process and help maintain visibility to current and future capital needs across the drug product program.

Qualifications

Required Qualifications:

• Bachelor's degree in Engineering or a related technical discipline with 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/forecasting, technical documentation, contract/vendor coordination, and executive communication.
• Ability to manage multiple priorities and make sound decisions in a fast-paced start-up and operational environment.

Preferred Qualifications:

• 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 is preferred.
• 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.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.