Process Development Engineer - Kilo/Pilot Plant

Infotree Global Solutions; Cambridge (MA); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

No travel required

Job summary

Infotree Global Solutions seeks a Chemical Engineer to partner with a multi-functional team through the process development cycle for synthetic API operations. You will design experiments, analyze data, perform risk assessments, and support kilo/pilot operations and equipment commissioning.

The role emphasizes scale-up, technology transfer, and collaboration with Manufacturing, Process Development, and Quality to ensure regulatory compliance and robust process understanding.

Qualifications

• Bachelor’s degree and 2 years of Engineering or Operations experience
• Associate’s degree and 6 years of Engineering or Operations experience
• High school diploma / GED and 8 years of Engineering or Operations experience
• Academic background in Chemical Engineering
• 2+ years in Process Development/Process Engineering environment
• Experience in peptide and/or oligonucleotide process development and manufacturing is preferred
• Hands-on experience with Prep LC, AEX, HIC, TFF, and UF/DF purification processes
• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
• Basic understanding of cGMP requirements
• Experience building and utilizing first principal models with proficiency across several modeling platforms
• Knowledge of analytical techniques and solid-state characterization with fluency in various techniques
• Background in statistical analysis/DoE
• Working knowledge of standard plant operations and safety practices
• Excellent project management skills
• Strong verbal communication and presentation skills

Responsibilities

• Evaluate, select and execute standard experimental, modeling and engineering techniques for process optimization, characterization, and scale up of synthetic APIs in state-of-the-art facilities.
• Initiate and complete technical tasks in lab, kilo/pilot plant
• Author documents for process understanding, transfer, risk assessment, facility fit, and development/characterization.
• Function as a technical expert to equipment or systems regarding troubleshooting
• Suggest problem resolution, provide troubleshooting guidance and recommend process improvements.
• Apply engineering principles and statistical analysis, including DoE, to solve processing issues and evaluate opportunities for improvements.
• Communicate and collaborate with Manufacturing, Process Development, and Quality departments.
• Contribute to regulatory and quality activities such as non-conformance, process performance qualification and continued process verification.

Skills

Process development

Design of experiments

Statistical analysis

cGMP understanding

Project management

Technical communication

Education

Bachelor’s degree in Chemical Engineering

Associate’s degree

High school diploma / GED

Tools

Prep LC

AEX

HIC

TFF

UF/DF

Job description

The Engineer will partner with a multi-functional group of engineers and scientists through the process development cycle at Client to develop and optimize synthetic unit operations aligned for the intended phase of technology transfer and commercial support. This includes experimental design and execution, data analysis, process risk analysis, process characterization, facility fit assessment, and support of kilo lab operations during process execution and equipment commissioning.

Domestic and International Travel: This role does not require travel.

The Engineer will be expected to:

• Evaluate, select and execute standard experimental, modeling and engineering techniques for process optimization, characterization, and scale up of synthetic active pharmaceutical ingredients in state-of-the-art facilities.
• Initiate and complete technical tasks in lab, kilo/pilot plant
• Author documents for process understanding, transfer, risk assessment, facility fit, and development/characterization.
• Function as a technical expert to equipment or systems regarding troubleshooting

operations.

• Suggest problem resolution, provide troubleshooting guidance and recommend process improvements.
• Apply engineering principles and statistical analysis, including design of experiments, in order to solve processing issues and evaluate opportunities for process improvements.
• Communicate and collaborate with Manufacturing, Process Development, and Quality departments.
• Contribute to key regulatory and quality activitie s such as non-conformance, process performance qualification and continued process verification.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual with these qualifications.

Basic Qualifications

Bachelor’s degree and 2 years of Engineering or Operations experience Or

Associate’s degree and 6 years of Engineering or Operations experience Or

High school diploma / GED and 8 years of Engineering or Operations experience

Preferred Qualifications:

• Academic background in Chemical Engineering
• 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of synthetic manufacturing processes
• Experience in peptide and/or oligonucleotide process development and manufacturing is preferred.
• Hands-on experience with Prep LC, AEX, HIC, TFF, and UF/DF purification processes.
• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
• Basic understanding of cGMP requirements
• Experience building and utilizing first principal models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms
• Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
• Background in statistical analysis/DoE
• Working knowledge of standard plant operations and safety practices
• Excellent project management skills
• Strong verbal communication and presentation skills