Engineering Project Manager in Dallas, Texas at Mark Cuban Cost Plus Drug Company

JOB TITLE: Engineering Project Manager DEPARTMENT: Engineering

REPORTS TO: Director of Engineering EMPLOYEE STATUS: Exempt

LOCATION: On-site WORK AVAILABLE: Full Time

SUMMARY

The Engineering Project Manager leads cross-functional capital, facility, equipment, and process engineering initiatives that strengthen MCCPDC's 503B sterile manufacturing infrastructure, technical readiness, and operational reliability. This role drives end-to-end project execution across equipment acquisition, facility expansion, utilities upgrades, automation integration, and manufacturing process improvements.

This manager plays a critical role in ensuring asset readiness, minimizing equipment downtime, improving production throughput, and enabling scalable growth as MCCPDC expands its sterile compounding and manufacturing footprint. The position interfaces heavily with Engineering, Maintenance, Validation, Production, Quality Assurance, Regulatory, Supply Chain, Finance, and IT.

KEY RESPONSIBILITIES

Capital & Engineering Project Leadership

• Lead small- to large-scale engineering and capital projects from initiation and design through installation, commissioning, and handover using structured project management methodologies.
• Own project charters, schedules, budgets, CapEx tracking, risk registers, stakeholder communication, and executive-level reporting.
• Develop business cases, ROI models, and cost-benefit analyses for proposed equipment, facility, and automation investments.
• Manage external engineering firms, equipment vendors, and contractors, including scope definition, bid evaluation, contract alignment, and on-site execution.

Equipment, Facilities & Automation Execution

• Coordinate specifications, procurement, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and installation of sterile processing, filling, packaging, and utility systems.
• Partners with Facilities and Maintenance teams to plan and execute cleanroom modifications, HVAC/utility upgrades, and infrastructure expansions with minimal disruption to active operations.
• Support manufacturing automation, PLC/SCADA upgrades, and equipment data-integration projects in collaboration with Automation Engineering and IT.
• Lead technical root-cause investigations for recurring equipment reliability issues and implement permanent engineering solutions.

Commissioning, Qualification & Validation (CQV) Alignment

• Partner closely with Validation and Quality teams to align project schedules with URS, DQ, IQ, OQ, and PQ milestones.
• Ensure engineering deliverables, turnover packages (TOPs), P&IDs, and redline drawings are complete, accurate, and approved prior to system release.
• Coordinate preventive maintenance (PM) setup, spare-parts readiness, and operator/technician training prior to production handover.

Production & Tech Transfer Support

• Analyze production bottlenecks, equipment capacity constraints, and changeover impacts; propose and execute targeted engineering improvements.
• Support technology transfers, new product introductions, and line scale-up initiatives with dedicated engineering project leadership.
• Collaborate with Production Managers to schedule shutdown windows, equipment tie-ins, and qualification runs cleanly around manufacturing campaigns.

Compliance & 503B Operational Alignment

• Ensure all engineering projects comply with cGMP, FDA 503B outsourcing facility requirements, OSHA safety standards, and MCCPDC's internal QMS.
• Manage engineering change controls, deviations, and CAPA actions tied to capital projects and equipment modifications.
• Support regulatory inspections and internal audits by providing engineering project documentation, system drawings, and compliance records.

Cross-Functional Collaboration & Communication

• Facilitate clear alignment between Engineering, Validation, QA/QC, Production, Supply Chain, Finance, and executive leadership.
• Build project dashboards and executive summaries detailing milestone progress, budget burn, critical- path risks, and mitigation plans.
• Provide structured updates during tiered operational meetings, capital review boards, and leadership reviews.

REQUIRED QUALIFICATIONS

• Bachelor's degree in Mechanical, Chemical, Electrical, Industrial, Biomedical Engineering, or a related technical discipline.
• 3–7+ years of experience in engineering, capital project management, manufacturing operations, or facilities/equipment engineering.
• Experience working in pharmaceutical, biotech, medical device, or other cGMP-regulated sterile manufacturing environments.
• Demonstrated track record leading cross-functional capital or technical projects from concept through qualification and handover.
• Strong analytical and technical problem-solving skills, including root-cause analysis, schedule/budget forecasting, and risk management.
• Proficiency with project management and engineering tools (e.g., MS Project, Smartsheet, AutoCAD/Bluebeam, CMMS, and Excel).
• Excellent communication, technical documentation, and vendor/stakeholder-management skills.

PREFERRED EXPERIENCE

• Direct experience in 503B sterile compounding, aseptic filling, or commercial sterile injectable manufacturing.
• Certifications: PMP (Project Management Professional), PE (Professional Engineer), or Lean Six Sigma Green/Black Belt.
• Hands-on familiarity with CQV lifecycles, cleanroom classifications (ISO 5/7/8), and critical utilities (WFI, clean steam, compressed gases).
• Experience managing cGMP change controls, engineering deviations, and CAPA investigations.

CORE COMPETENCIES

• Strategic Thinking & Systems-Level Technical Problem Solving
• Capital Project & Program Management
• Data-Driven Decision Making & Budget Discipline
• Vendor, Contractor & Cross-Functional Stakeholder Management
• Continuous Improvement & Operational Excellence
• Strong Written, Technical & Verbal Communication
• Bias for Action, Ownership, and Follow-Through

PERFORMANCE INDICATORS (KPI’s)

• On-time and on-budget completion of capital and engineering projects
• Equipment and facility readiness achieved ahead of scheduled production campaigns
• Reduction in equipment downtime, process bottlenecks, and changeover times
• First-time-right execution of FAT, SAT, and IQ/OQ/PQ turnover packages
• Improvement in manufacturing throughput and capacity tied to engineering initiatives
• Internal customer satisfaction (Production, QA/Validation, Maintenance)
• cGMP documentation, change-control, and safety compliance accuracy