Senior Project Engineer

Description About Us: Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Job Summary The Senior Project Engineer leads complex engineering and capital projects supporting blending, coating, and packaging operations. This role manages the full lifecycle of projects from concept through design, execution, commissioning, and validation. The position provides advanced process engineering expertise, oversees project controls including budget and forecasting, and ensures compliance with safety, regulatory, and GMP requirements. The Senior Project Engineer also mentors junior engineers and collaborates cross-functionally with Operations, R&D, Quality, and Maintenance to support manufacturing performance and continuous improvement.

Job Responsibilities

• Lead capital projects involving installation, upgrade, and optimization of equipment.
• Manage full project lifecycle including scope development, engineering design, procurement, installation, commissioning, and validation.
• Perform advanced process engineering analysis to select appropriate equipment technologies and improve manufacturing processes.
• Prepare capital project requests including cost estimates, schedules, technical justification, and ROI analysis.
• Manage project controls including forecasting, budget tracking, and schedule management.
• Ensure projects meet design specifications, safety standards, regulatory requirements, and project timelines.
• Evaluate and implement process control systems, monitoring technologies, and data acquisition systems.
• Lead development and execution of validation master plans and IQ/OQ/PQ protocols for equipment, facilities, and processes.
• Develop and maintain engineering documentation including URS, commissioning protocols, SOPs, work instructions, PM programs, and training materials.
• Assess equipment and facility modifications for regulatory impact and revalidation requirements.
• Support R&D scale-up activities and manufacturing process improvements.
• Coordinate with production, quality, validation, and maintenance teams to support project implementation.
• Provide technical leadership and mentorship to junior engineers.
• Ensure compliance with GMP, safety, and regulatory standards.
• Perform other duties as assigned.

Qualifications Education:

• B.S. degree in Engineering (Chemical, Mechanical, Industrial, or related field)

Knowledge, Skills And Abilities

• Strong knowledge of Current Good Manufacturing Practices (cGMPs), FDA regulations, and pharmaceutical or regulated manufacturing environments.
• Advanced knowledge of capital project management, process engineering, and manufacturing systems.
• Experience with process control systems, automation, and data acquisition technologies.
• Strong technical writing skills for engineering documentation and regulatory submissions.
• Ability to read, analyze, and interpret scientific and technical journals, financial reports, and regulatory documentation.
• Ability to present complex technical information to senior leadership and cross-functional teams.
• Advanced analytical and statistical problem-solving capabilities including:
• Design of Experiments (DOE)
• Reliability Centered Maintenance (RCM)
• Statistical analysis and variance analysis
• Sampling theory and correlation analysis
• Strong leadership, project management, and organizational skills.
• Ability to manage multiple projects simultaneously in a fast-paced manufacturing environment.
• Experience:
• Minimum 10–15 years of engineering experience in manufacturing, pharmaceutical, chemical, or related regulated industries..