Project Manager-Engineering (Pharmaceutical Manufacturing)

Location: Middletown, DE, US. On-site.

Company

hirify.global operates a drug product manufacturing facility where this role supports engineering and capital projects.

What you will do

• Lead capital and engineering projects from initiation, scope definition, business-case development, and funding through design, procurement, installation, commissioning, qualification, turnover, and closeout.
• Own project scope, schedule, budget, commitments, forecasts, risks, changes, funding structures, procurement execution, and financial closeout.
• Coordinate URS, design criteria, layouts, technical specifications, bid packages, procurement strategies, integrated schedules, action trackers, and executive status updates.
• Lead design reviews, vendor selection, FAT, site readiness, installation, SAT, commissioning, qualification, operational turnover, and resolution of technical issues and punch-list actions.
• Manage OEMs, A/E firms, contractors, integrators, service providers, and cross-functional stakeholders across Manufacturing, Technical Services, CQV, Automation/CSV, Facilities, Quality, EHS, Finance, and Procurement.
• Ensure cGMP, Quality, EHS, permitting, change-control, documentation, handover, lessons learned, and transition requirements are completed.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline and 7+ years of relevant engineering, capital-project, or pharmaceutical manufacturing experience, including demonstrated project leadership.
• Experience managing capital projects through multiple lifecycle phases, including concept/design, procurement, construction or 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 have

• 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.

Culture & Benefits

• Individual-contributor role with no direct reports.
• Cross-functional collaboration across site leadership, Engineering, Operations, Quality, Finance, Procurement, and external partners.
• Work is performed on-site at the Middletown drug product facility.