Project Engineer

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 Project Engineer responsible for supporting the design and implementation of equipment technology for manufacturing processes, as well as preparing capital project request reports. The ideal candidate will manage project controls, including forecasting and spending, and ensure that all process control, monitoring, and data acquisition requirements are met for the successful execution of engineering projects.

This role will focus on the installation and upgrading of equipment for adhesive blending, coating, and packaging, ensuring projects are delivered on time, within budget, and meet all safety and regulatory standards.

Key Responsibilities:

• Process Design & Equipment Selection: Perform basic process engineering design to select the appropriate equipment technology for given manufacturing processes.
• Project Planning & Reporting: Prepare detailed capital project request reports for engineering projects. Provide accurate forecasts and spending reports for project portfolios.
• Project Implementation: Oversee project execution, ensuring that design criteria, safety standards, budgets, and timelines are met throughout all stages of the project.
• Validation Master Plan Development: Develop validation master plans for equipment, facilities, computerized systems, cleaning, and processes (IQ/OQ/PQ).
• Protocol Development & Reporting: Write and manage IQ/OQ/PQ protocols and summary reports for equipment, facilities, systems, and cleaning processes.
• Scheduling & Updates: Prepare, revise, and update schedules for validation activities, ensuring alignment with project timelines.
• Standard Operating Procedures (SOPs) & Maintenance Programs: Develop SOPs, preventive maintenance (PM) schedules, and calibration programs for equipment, instruments, facilities, and processes during startup.
• Impact Study & Revalidation: Conduct impact studies for equipment, support systems, and facility modifications or repairs, determining revalidation requirements.
• Maintenance & Training Support: Ensure maintenance support, operator training, and process equipment training are adequate for efficient operations.
• Collaboration with Production & R&D: Interface with production and R&D management to schedule and execute current projects, assisting in equipment planning and operational issues during scale-up.
• GMP Documentation Support: Support GMP documentation for modifications to existing and new equipment, including User Specification Requirements, commissioning protocols, work instructions, and training materials. Assist in the creation and revision of SOPs, safety procedures, and other regulatory documents.
• Project Support: Assist Senior Engineers and P.E. II Engineers on large-scale projects, contributing to the successful completion of engineering initiatives.
• Compliance & Values Adherence: Perform work in alignment with our corporate values of Pride, Accountability, Integrity, and Diligence. Adhere to regulatory compliance, safety standards, and our Code of Conduct.
• Team Collaboration: Work collaboratively within a team to achieve project goals and meet organizational objectives.
• Other Duties: Perform other relevant duties as assigned by management.

Education:

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or related field.

Experience:

• Ten years related experience and/or training; or equivalent combination of education and experience. 
• Proven experience in process engineering, equipment selection, and project management.
• Strong understanding of manufacturing processes, especially in adhesive blending, coating, and packaging.
• Familiarity with validation protocols (IQ/OQ/PQ), GMP documentation, and regulatory compliance requirements

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Knowledge, Skills and Abilities:

• Business English usage, spelling, grammar and punctuation.
• Basic mathematical and statistical computation methods and practices.
• Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to common inquires or complaints from regulatory agencies, or members of the business community.
• Ability to effectively present information to management.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. 
• Ability to apply mathematical operations to such tasks as frequency distribution, DOE, RCM (Reliability Centered Maintenance), analysis of variance, correlation techniques, sampling theory, and factor analysis.

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Benefits:

Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan

• Medical/Dental/Vision Insurance
• Paid Time Off
• 401k with employer match
• Paid Holidays and Floating Holiday

Equal Opportunity Employer