Our organization is seeking a highly skilled Project Engineer to join our team. This role involves managing the planning, design, procurement, construction, commissioning, and qualification phases of capital expenditure (CAPEX) projects at a biopharmaceutical manufacturing facility.
The successful candidate will be responsible for leading and supporting the end-to-end delivery of engineering CAPEX projects from concept to handover. This includes developing detailed project scopes, objectives, schedules, budgets, and resource plans. Additionally, they will coordinate with cross-functional teams, including manufacturing, quality, regulatory, and safety, to ensure compliance with regulatory and safety standards.
Responsibilities:
* Support or lead the end-to-end delivery of engineering CAPEX projects from concept to handover
* Develop detailed project scopes, objectives, schedules, budgets, and resource plans
* Coordinate with cross-functional teams, including manufacturing, quality, regulatory, and safety
* Collaborate with internal stakeholders and external engineering firms to develop design specifications, P&IDs, and layouts
* Evaluate technical expertise and troubleshooting during design, installation, and commissioning
* Prepare requests for proposals (RFPs) and evaluate supplier bids
* Manage vendor and contractor performance, ensuring adherence to technical specifications and project timelines
* Oversee the procurement of equipment, materials, and services required for project execution
* Supervise on-site activities, ensuring safe, efficient, and high-quality construction practices
* Develop and execute commissioning plans, including equipment testing, system integration, and performance verification
* Coordinate validation activities to meet GMP and regulatory requirements
* Monitor project budgets, track expenditures, and report on financial performance
* Identify and mitigate project risks, including scope changes and schedule impacts
* Prepare regular status updates, technical reports, and project documentation
In addition to these responsibilities, the Project Engineer will also be expected to promote and maintain a strong safety culture throughout all project phases, perform risk assessments, and ensure proper permits are obtained.
Qualifications:
* Bachelor's degree in Engineering (e.g., Mechanical, Chemical, Electrical, or related field)
* 3-5 years of experience in project engineering, preferably in the biopharma, pharmaceutical, or related process industries
* Proven track record of delivering CAPEX projects within a GMP-regulated environment
* Strong knowledge of engineering principles, equipment, and systems used in biopharma manufacturing
* Proficiency with project management tools (e.g., MS Project, Primavera) and CAD software
Benefits:
The successful candidate will have the opportunity to work on challenging and complex projects, develop their skills and expertise, and contribute to the success of our organization. We offer a dynamic and supportive work environment, competitive compensation and benefits package, and opportunities for professional growth and development.