Project Engineer C&Q

The Innovative Medicine Supply Chain (IM SC) is seeking a Project Engineer. The Project Engineer reports to the Engineering Design & Project Delivery Lead.

This role is responsible for scoping and leading engineering projects within a pharmaceutical manufacturing environment (drug product), with a primary focus on aseptic compounding and filling. Example projects include the procurement of isolators, compounding and filling equipment, and/or supporting systems used in the production of parenteral drugs (e.g., parts washers, autoclaves, PUPSIT filter testers, CCIT testing equipment, etc.).

Responsibilities

Project Leadership

• Lead engineering projects, ensuring project scope, priorities, resources, capabilities, and processes are clearly defined and in place.
• Align with project sponsors and bring together core and extended teams to deliver the final project objectives.
• Prepare project intake documentation, including scope definition, business case analysis, alternatives assessment, and presentation of the recommended option for approval.
• Facilitate project planning, monitoring, and reporting against key deliverables and objectives.
• Apply standardized project management methodologies to ensure flawless project execution.
• Manage project finances: secure accurate budget allocation upon approval and control spending during implementation and post-project care.
• Oversee all technical engineering activities from conceptual design through construction and qualification, including coordination with internal resources and external contractors/suppliers.
• Identify and manage project risks using appropriate risk management techniques.
• Ensure sound technical engineering practices are applied throughout all phases of the project.
• Provide regular project updates to stakeholders including project sponsors, engineering leads, operations, and quality departments.
• Ensure full compliance with Environmental, Health, Safety, and Sustainability (EHSS) standards.

Qualifications

• A technical education / degree in an engineering discipline is required.
• 2-5 years of experience in a relevant field is preferred.
• Experience in a GMP-regulated environment is a plus.
• Solid background in aseptic processing is highly desirable.
• Experience with risk-based qualification methodologies is an advantage.