Specialist - Project
7 days ago
Job Summary:
The Project Engineer supports the execution of pharmaceutical facility expansion projects, ensuring compliance with GMP, safety, and regulatory requirements. This role involves coordinating with internal stakeholders, external consultants, contractors, and vendors to deliver projects on time, within budget, and to required quality standards.
Key Responsibilities:
1. Project Planning & Coordination
• Support project managers in planning and scheduling engineering and construction activities.
• Assist in developing project scope, technical specifications, URS (User Requirement Specifications), and design deliverables.
• Coordinate design reviews, constructability assessments, and GMP compliance checks.
• Liaise with cross-functional teams (Production, QA/QC, EHS, Validation, Engineering, Procurement).
2. Execution & Supervision
• Oversee installation, commissioning, and qualification (IQ/OQ/PQ) of process and utility systems.
• Supervise contractors and ensure adherence to project safety, quality, and GMP standards.
• Monitor construction progress, manage site issues, and report project status.
3. Technical & Compliance Support
• Ensure all designs and installations comply with cGMP, NEA, MOM, SCDF, and other local regulations.
• Support validation and handover documentation.
• Participate in FAT/SAT and equipment acceptance testing.
4. Budget & Schedule Control
• Track project expenditures, prepare cost reports, and support change management.
• Assist in vendor and contractor evaluation, quotation comparison, and technical clarifications.
5. Continuous Improvement
• Contribute to energy efficiency, sustainability, and digitalization initiatives in plant expansion projects.
• Identify opportunities for process and utility optimization.
Qualifications:
Education:
• Bachelor's Degree in Mechanical, Electrical, Chemical, or Industrial Engineering (or related discipline).
• PMP or PRINCE2 certification is advantageous.
Experience:
• 3 years above of experience in pharmaceutical, biotech, or advanced manufacturing project environments.
• Hands-on experience with cleanroom design, HVAC, process utilities (WFI, clean steam, compressed air, etc.), production equipment installation.
• Familiar with GMP, GEP, and EHS standards in regulated industries.
• Experience in CAPEX projects, plant expansion, or facility retrofits preferred.
Skills:
• Strong project coordination and stakeholder management.
• Knowledge of validation and qualification processes (DQ/IQ/OQ/PQ).
• Proficient in MS Project or Primavera; AutoCAD or BIM experience a plus.
• Strong analytical, communication, and documentation skills.
Personal Attributes:
• Team-oriented with a proactive, problem-solving mindset.
• Able to work in a fast-paced, multi-disciplinary environment.
• Detail-oriented and committed to safety and compliance.
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