Sr. Mechanical Engineer - Project Management

Job Description

Join a premier research‑intensive biopharmaceutical organization at the forefront of delivering innovative health solutions. As a Sr Mechanical Engineer - Project Management, you will lead the engineering lifecycle for capital and improvement projects in a highly regulated environment, combining deep mechanical engineering expertise with rigorous project, portfolio, and stakeholder management. You will drive projects from concept through commissioning/qualification, ensure safety and quality compliance, optimize cost and schedule, and enable cross‑functional teams to deliver reliable, efficient, and compliant operations.

• Own mechanical scope for projects across utilities, process equipment, facilities, and packaging/HVAC systems; develop URS/FRS/DDS and review provider deliverables
• Read and interpret engineering drawings, P&IDs, schematics, equipment manuals; perform and/or oversee design reviews (constructability, maintainability, ergonomics)
• Specify, evaluate, and select equipment; participate in FAT/SAT, punchlist resolution, and turnover to operations/maintenance
• Lead or manage development and execution of Commissioning, Qualification, and Validation (CQV) protocols for system changes and upgrades
• Ensure mechanical integrity and reliability; apply root‑cause analysis and corrective/preventive actions across safety, compliance, automation, equipment, process, and people dimensions
• Develop and update SOPs and Energy Control Procedures, train end users on system interfaces and applications

• Define project scopes, deliverables, success criteria, and intake documents; align with Global/Site Engineering, EHS, Quality, and Operations
• Build and manage integrated schedules (e.g., MS Project) and stage‑gates from concept through closeout; lead cross‑functional project team meetings
• Develop cost estimates, budgets, and forecasts; track performance, risks, and changes; issue POs/change orders and verify/approve supplier invoicing
• Manage vendors, contractors, and consultants; ensure use of Job Safety Assessments during construction and at turnover
• Open and track Quality Change Requests and Safety Management of Change (MOC); coordinate Process Hazard Analyses and execution of action plans
• Conduct ergonomic, industrial hygiene, and other safety‑related assessments and drive resulting action plans
• Close out projects, ensure asset capitalization, and assign depreciation profiles with Accounting/Finance

• Establish and apply project governance frameworks, policies, and standardized processes; drive reuse of lessons learned and knowledge management
• Centralize and communicate critical project information; deliver timely updates to stakeholders and senior leadership to support decisions
• Plan and schedule resources across the portfolio; conduct divisional portfolio and KPI reviews to optimize throughput and compliance
• Mentor and coach project managers/engineers; facilitate key team meetings, resolve conflicts, and enhance cross‑functional team dynamics
• Analyze financials (budgets, risks, resource allocation) and provide financial reports and budget outlines to leadership
• Maintain schedules and critical data in enterprise project management systems; support change management and communications plans

• Ensure adherence to cGMP, OSHA/EHS, and applicable regulatory/industry standards for pharmaceutical/USDA‑regulated environments
• Lead or support audits/inspections related to engineering changes, equipment, and facilities
• Champion Lean/Six Sigma and continuous improvement to enhance safety, quality, reliability, and energy efficiency

• Bachelor’s degree in Mechanical Engineering (or closely related engineering discipline)
• 5–10+ years of experience delivering mechanical engineering projects in highly regulated industries (biotech, pharma, food, nuclear, or energy), including end‑to‑end project management of $250K–$10M projects
• Demonstrated ability to develop engineering specifications (URS/FRS/DDS), read/interpret drawings and P&IDs, and lead FAT/SAT and CQV…