About The Position

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.

Requirements

  • 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 activities
  • Proven experience establishing and managing schedules, budgets, risk registers, and change control; proficiency with MS Project and office productivity tools
  • Strong problem solving and root-cause analysis across safety, compliance, automation, equipment, and process domains
  • Excellent communication, leadership, stakeholder management, and team facilitation skills; ability to influence across functions and levels
  • Working knowledge of regulatory/industry requirements for tightly regulated environments; familiarity with quality change control and MOC
  • Ability to work in manufacturing environments with exposure to temperature extremes, noise, moving mechanical parts, and production chemicals

Nice To Haves

  • Experience in USDA-regulated and/or pharmaceutical manufacturing sites and capabilities
  • PMP (Project Management Professional) or equivalent project management certification
  • Lean/Six Sigma training or certification
  • Experience with SAP or similar CMMS/ERP for parts, maintenance history, and asset data
  • Working knowledge of end-to-end supply chain processes and their impact on engineering projects
  • Advanced English; strong presentation skills and business acumen

Responsibilities

  • Mechanical engineering and technical leadership
  • 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
  • Project management and delivery
  • 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
  • PMO, governance, and portfolio enablement
  • 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
  • Compliance, safety, and quality
  • 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

Benefits

  • medical
  • dental
  • vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
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