Capital Project Engineer – API Pilot Plant & R&D Facilities

Key Responsibilities

• Lead the planning and execution of small-to-medium capital projects (up to $5M) supporting API manufacturing and laboratory operations.
• Manage projects involving new process equipment installations, facility modifications, and infrastructure upgrades.
• Define project scope, schedules, budgets, and resource requirements while ensuring alignment with business objectives.
• Cook up cross-functional teams including Engineering, Manufacturing, Facilities, Quality, EHS, and external contractors.
• Develop project execution strategies, procurement plans, and cost estimates while maintaining project controls for scope, schedule, and budget.
• Conduct feasibility studies, engineering evaluations, and economic analyses to support project decisions.
• Design and oversee process systems, equipment, utilities, instrumentation, and facility improvements.
• Review and develop engineering deliverables including P&IDs, equipment specifications, process calculations, and technical documentation.
• Ensure compliance with applicable engineering standards, cGMP requirements, environmental regulations, OSHA standards, and building/fire codes.
• Support commissioning, qualification, and validation activities, including User Requirement Specifications (URS), protocol development, and execution.
• Perform risk assessments and implement mitigation strategies to ensure project success.
• Provide regular project updates to stakeholders and senior leadership.
• Drive innovation, continuous improvement, and implementation of emerging technologies within project designs.

Required Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline.
• 10+ years of engineering and capital project management experience within pharmaceutical, chemical, API, or related regulated industries.
• Strong knowledge of pharmaceutical process systems, equipment design, and facility engineering.
• Experience developing and reviewing: P&IDs, process equipment specifications, instrumentation and control systems, engineering design packages.
• Proven experience managing capital projects from concept through construction, commissioning, and startup.
• Experience with project budgeting, cost control, scheduling, procurement, and contractor management.
• Familiarity with commissioning, qualification, and validation (CQV) activities.
• Working knowledge of FDA cGMP regulations, OSHA requirements, environmental regulations, and building codes.
• Strong leadership, communication, and stakeholder management skills.
• Able to manage multiple projects simultaneously in a fast-paced environment.