Position Overview

We are seeking a skilled Project Engineer to support and lead key elements of a major facility expansion project within a highly regulated manufacturing environment. This role will focus on the design, coordination, execution, and validation of facility and process equipment upgrades, ensuring all work meets applicable regulatory and quality standards.

The ideal candidate will have hands-on project management experience in facility and equipment expansions within regulated industries, along with strong technical knowledge and a collaborative mindset.

Key Responsibilities

Project Planning & Execution

• Assist in the planning and delivery of facility and equipment expansion projects, including cleanroom construction, HVAC systems, utilities, and process equipment installations.
• Collaborate with cross-functional teams to ensure project compliance, schedule adherence, and budget control.
• Maintain and update project schedules, timelines, and budget reports.

Engineering & Technical Oversight

• Review and approve engineering drawings, P&IDs, specifications, and layouts.
• Evaluate and plan utility and process system requirements (e.g., purified water, compressed air, HVAC).
• Oversee design and installation of processing and packaging lines.

Vendor & Contractor Coordination

• Work closely with external contractors, vendors, and consultants for design-build, commissioning, and qualification activities.
• Manage procurement, delivery, and installation of materials and equipment.

Compliance & Documentation

• Ensure all work adheres to relevant regulatory requirements and internal quality standards.
• Support validation activities including IQ/OQ/PQ protocol development and execution.
• Prepare and maintain comprehensive project documentation, change controls, and engineering reports.

Safety & Risk Management

• Enforce safety procedures throughout project execution.
• Conduct and document risk assessments, implementing mitigation strategies as required.

Qualifications

Education:

• Bachelor’s degree in Mechanical, Chemical, Industrial Engineering, or a related technical discipline.

Experience:

• 3–7 years of engineering or project management experience in a regulated manufacturing facility.
• Proven track record in facility and process equipment expansion projects.

Skills & Knowledge:

• Strong understanding of regulatory compliance, quality standards, and validation processes.
• Proficient in AutoCAD, MS Project, and other project management tools.
• Excellent communication, organizational, and leadership skills.

Preferred:

• PMP certification or formal project management training.