Project Engineer

From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

As a Project Engineer at Azzur Group, you will play a pivotal role in the successful execution and management of customer corporate CAPEX (Capital Expenditure) and site-specific OPEX (Operational Expenditure) projects of medium to high complexity in the Life Sciences industry. The ideal candidate will have a minimum of 2 years of experience, demonstrating a proven track record in delivering projects on time and within scope. This role requires a detail-oriented and results-driven professional with a passion for excellence in project execution. The following is a short list of the typical responsibilities and deliverables of any given project.

• Execute and assist in the management of customer corporate CAPEX and site- specific OPEX projects, ensuring adherence to project timelines, budgets, and quality standards.
• Work closely with internal and external stakeholders, including clients, project teams, and vendors, to understand project requirements and expectations.
• Proactively identify and mitigate project risks and issues, implementing corrective actions as needed.
• Develop and execute change control documents to manage alterations effectively, ensuring alignment with project objectives.
• Develop design specifications, including User Requirement Specifications (URS), Functional Specifications (FS), and Design Specifications (DS) to guide project development.
• Conduct Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) to validate the functionality and compliance of systems and equipment.
• Develop and execute thorough commissioning test protocols to ensure the successful integration and functionality of systems.
• Review and comprehend various construction drawings, including Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), and architectural, mechanical, and electrical drawings.
• Draft Standard Operating Procedures (SOPs) pertaining to the operation, maintenance, and calibration of equipment, utilities, and facilities.
• Collaborate in supporting Failure Modes and Effects Analysis (FMEAs) on equipment and utility systems, contributing to risk assessment and mitigation strategies.

Requirements

Qualifications

• BS in Engineering, Science or equivalent technical degree.
• Minimum of 2 years of experience in project engineering within the pharmaceutical and/or medical device industry.
• Experience working with Air Handling Units (AHUs) is preferred.
• Proven track record of successfully managing projects of medium to high complexity.
• Strong project management skills, including the ability to create and execute detailed project plans.
• Solid understanding of GMP regulations and industry standards.
• Experience in executing validation protocols and generating thorough documentation.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a dynamic team environment.