Senior Process Engineer - Reagent Process Development (Diagnostics)

Location: On-site in Roswell, Georgia, United States. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available.

Salary: $115,000–$120,000 annually, depending on experience.

Company

hirify.global develops and manufactures diagnostic technologies, analyzers, reagents, and consumables for veterinary and human healthcare.

What you will do

• Lead process development, scale-up, characterization, validation, and technology transfer for new diagnostic products and novel materials programs moving from R&D into manufacturing.
• Scale laboratory formulations to production volumes, establish process parameters and operating ranges, and develop specifications, acceptance criteria, test methods, and process controls.
• Design and run process characterization, design verification and validation, stability, and process validation studies.
• Develop synthesis and manufacturing processes from feasibility through optimization, process safety evaluation, and manufacturing readiness.
• Investigate manufacturing challenges using statistical analysis, root cause analysis, corrective and preventive action, troubleshooting, and risk assessment.
• Lead cross-functional projects, support equipment and technology decisions, maintain SOPs and work instructions, transfer knowledge to manufacturing, and mentor engineers and scientists.

Requirements

• Bachelor’s degree in Chemical Engineering, Chemistry, Biochemistry, Materials Science, a related engineering or scientific discipline, or an equivalent combination of education and experience.
• Significant experience in process development, scale-up, and manufacturing process design, with a strong foundation in chemical engineering principles and solution formulation.
• Experience with process characterization, design verification and validation, process validation, change management, stability studies, specifications, and process control strategies.
• Proficiency in statistical analysis and Design of Experiments (DOE), with data-driven and risk-based decision-making.
• Experience with troubleshooting, root cause analysis, process risk assessment, organic synthesis, reaction development, materials or polymer processing, and process safety evaluation.
• Experience supporting technology transfer and manufacturing readiness, including SOPs, work instructions, and process documentation.
• Knowledge of ISO, GMP, quality, safety, and environmental requirements, including the ability to interpret applicable standards, specifications, and technical literature.
• Ability to work independently and collaboratively, lead cross-functional teams, manage multiple priorities, communicate technical concepts to technical and non-technical audiences, and support junior team members’ development.
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint, Visio, and Project, and statistical or engineering software such as JMP or Minitab.

Nice to have

• Master’s degree or PhD in a related field.
• Experience with SAP.
• Familiarity with Lean, Six Sigma, or other continuous improvement methodologies.

Culture & Benefits

• Collaborative environment emphasizing curiosity, continuous improvement, diverse perspectives, learning, and discovery.
• Health, dental, and vision benefits starting on day one.
• Annual cash bonus opportunity, 5% 401(k) company match, performance-based merit increases, paid time off, and paid holidays.
• Financial well-being resources, mental health support, wellness programs, paid volunteer time, and foundation donation matching.