Senior Process Engineer - Reagent Process Development

Idexx•Roswell, GA

6d•Onsite

About The Position

The Senior Process Engineer in Reagent Process Development transforms innovative reagent chemistries and laboratory formulations into reliable, scalable manufacturing processes. The role supports future platform launches, strategic innovation programs, and diagnostic product development, helping prepare new technologies for manufacturing and market launch. The Roswell site develops and manufactures point-of-care blood gas and electrolyte analyzers and related consumables for human healthcare, as well as consumables used in IDEXX veterinary analyzers. The engineer leads process development, scale-up, characterization, validation, and technology transfer for products moving from R&D into manufacturing. Responsibilities span formulation scale-up, synthesis and manufacturing process development, stability and verification studies, process controls, troubleshooting, equipment recommendations, documentation, and manufacturing readiness. The role also influences technical strategy, leads cross-functional project teams, partners with internal and external stakeholders, mentors junior colleagues, and applies Lean and continuous improvement principles. This is an on-site position at the Roswell, Georgia location. Applicants must be authorized to work for any U.S. employer; visa sponsorship is not available.

Requirements

Bachelor’s degree in Chemical Engineering, Chemistry, Biochemistry, Materials Science, another 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, and change management.
Experience designing stability studies, developing specifications, and implementing process control strategies.
Skill in statistical analysis and Design of Experiments (DOE), with the ability to make data-driven, risk-based decisions.
Experience with troubleshooting, root cause analysis, and process risk assessment methods.
Background in organic synthesis, reaction development, and materials or polymer processing, including process safety evaluation.
Experience supporting technology transfer and manufacturing readiness, including developing SOPs, work instructions, and process documentation.
Knowledge of ISO, GMP, quality, safety, and environmental requirements, and ability to interpret applicable standards, specifications, and technical literature.
Ability to work independently and collaboratively, lead cross-functional teams, manage multiple priorities, and support the growth of junior team members.
Clear written, verbal, and presentation communication skills, including the ability to explain technical concepts to technical and non-technical audiences.
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Visio, and Project) and statistical or engineering software such as JMP or Minitab.
Authorization to work for any employer in the United States; visa sponsorship is not available.

Nice To Haves

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

Responsibilities

Lead process development, scale-up, characterization, validation, and technology transfer for new products moving from R&D into manufacturing.
Scale formulations from laboratory batches to production volumes and identify and mitigate technical risks.
Establish process parameters and operating ranges, and develop manufacturing specifications, acceptance criteria, and test methods.
Design and conduct process characterization studies, design verification and validation activities, stability studies, and process control strategies.
Develop synthesis and manufacturing processes from feasibility through optimization, process safety evaluation, and manufacturing readiness.
Investigate manufacturing and development challenges using data-driven problem solving, root cause analysis, and corrective and preventive action methods.
Recommend, justify, and implement equipment and technologies that support quality, efficiency, and business goals.
Develop and maintain process documentation, SOPs, and work instructions; support training and knowledge transfer to manufacturing teams.
Lead and influence cross-functional project teams, develop project plans and timelines, and communicate progress to stakeholders and leadership.
Partner with R&D, Manufacturing, Quality, Supply Chain, Regulatory Affairs, and external supplier and vendor partners.
Mentor engineers and scientists and contribute to technical strategy and future direction.
Apply Lean and continuous improvement principles to strengthen process performance and operational excellence.