Senior Project Engineer (Pharmaceutical Manufacturing)

Location: Melrose Park (Ruby St), United States; onsite

Salary: $100,000–$115,000 per year, plus eligibility for an annual bonus with a 6% target of base salary.

Company

hirify.global develops and manufactures pharmaceutical and nutritional products, including parenteral nutrition and generic pharmaceuticals.

What you will do

• Lead engineering design, development, scale-up, and technology transfer for complex pharmaceutical formulations and manufacturing processes.
• Develop and improve processing technologies including high-pressure homogenization, microfluidization, lyophilization, spray-freeze-drying, steam sterilization, and UHT sterilization.
• Lead equipment and process projects from URS development and procurement through commissioning, qualification, installation, start-up, and early production support.
• Develop conceptual designs, P&IDs, 3D models, shop drawings, isometric drawings, process specifications, and operating instructions.
• Design and execute engineering studies, analyze production problems, and implement process improvements for aseptic formulation and filling.
• Coordinate contractors, vendors, and multidisciplinary international teams to deliver projects safely, on time, within budget, and in compliance with GMP, FDA, OSHA, environmental, and local requirements.

Requirements

• Bachelor’s degree in chemical, process, pharmaceutical engineering, or a related field; an advanced degree is strongly preferred.
• At least 5 years of pharmaceutical industry experience focused on complex formulations and manufacturing technologies.
• At least 5 years of hands-on experience with validated manufacturing process systems and batch or continuous process design and implementation.
• Experience with emulsion formulation and processing, lyophilization formulation design, freeze-drying optimization and scale-up, experimental design, and data analysis.
• Experience with process control and instrumentation, sanitary connections, valves, pharmaceutical process design, and AutoCAD or SolidWorks.
• Excellent verbal and written communication skills; knowledge of cleanrooms, critical utilities, CIP/SIP, or potent API equipment is beneficial.

Nice to have

• Project management experience in a food, pharmaceutical, or regulated environment.
• Experience with WFI, OFCA, clean steam, HVAC, or equipment for cytotoxic or potent API products.
• Six Sigma training.

Culture & Benefits

• Full-time employment with comprehensive health benefits, including medical, prescription drug, dental, and vision coverage.
• 401(k) plan with company contributions.
• Paid vacation, holidays, and personal days.
• Life insurance, disability coverage, employee assistance, and wellness programs.
• Employment is at-will in accordance with applicable federal and state laws.