Project Engineer

Responsibilities

• Supports capital projects in the manufacturing plant, including front end planning activities.
• Covers coordination of multiple parties to complete project scopes on schedule, stay within budget, and meet the expected quality.
• Aids in the design of new equipment systems from preliminary design, specifications, budgeting, scheduling, and construction management.
• Develops project schedules including setting targets for milestone activities and adhering to deadlines.
• Tracks progress to ensure the project scope, cost, and schedule are being met.
• Manages the life-cycle documentation of the equipment including generation and approval of user requirements, equipment and instrument specifications, equipment test plans, and system operating procedures.
• Develops documents for FAT, SAT, and qualification activities for equipment.
• Participates in FAT, SAT, startup, commissioning and qualification of equipment.
• Writes scope of work documents, awards contracts, obtains estimates, selects suppliers, and purchases equipment and services.
• Reviews drawings, supervises contractors, and participates in final project acceptance upon completion of construction.
• Makes effective decisions when presented with multiple options for how to progress with the project.
• Communicates with management to keep the project aligned with their goals.
• Performs quality control on the project throughout development to maintain the standards expected.

Requirements

• Bachelor's Degree in Engineering, Science, or closely related discipline, or equivalent technical experience plus demonstrated competence.
• Technical background in Pharmaceutical or similar GMP-regulated industry.
• Expertise in equipment design, design specifications, and PFD/P&ID development.
• Experience with manufacturing equipment commissioning and qualification.
• Familiarity with PLC control systems.
• Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
• Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
• Works well with other engineers in a collaborative, fast-paced goal-driven environment.
• Possesses interpersonal skills to negotiate and reconcile differences.
• Understanding and management of procurement & contracting processes.
• Experience with automation and controls engineering.
• Experience with drug product and oral solid dosage manufacturing and equipment.