Automation-Driven Process Development Engineer

Orchestra BioMed; Fort Lauderdale (FL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

PTO & sick time

Job summary

Orchestra BioMed is seeking an experienced Process Development Engineer to translate manual manufacturing into automation-ready processes and to scale up production. You will work on process characterization, critical parameter identification, and technology transfer with internal teams and external partners.

The role requires hands-on work on automated equipment, DOE studies, and strong documentation in a regulated development environment, with a focus on scalable, validated manufacturing

Qualifications

• Bachelor’s degree in a related engineering or scientific discipline.
• 3–5 years of experience in regulated pharmaceutical, biotech, or medical device manufacturing.
• Hands-on experience with manufacturing, development, or characterization batches.
• Experience defining or optimizing manufacturing process parameters.
• Familiarity with DOE concepts and automated process equipment.

Responsibilities

• Plan and execute process characterization studies on automated process equipment.
• Perform hands-on characterization batches and designed experiments.
• Develop study matrices with senior staff and SMEs.
• Own data collection, organization, and analysis of characterization results.
• Define process setpoints, durations, tolerances, and end‑point criteria.
• Author executable batch records for automated manufacturing equipment.
• Support commissioning, IQ/OQ, and technology transfer activities.

Skills

DOE concepts

Process characterization

Automation awareness

Cross-functional collaboration

Data analysis

Education

Bachelor’s degree in Mechanical/Process/Biomedical Engineering

3–5 years in regulated pharma/biotech/medical device

Tools

PLC/SCADA controls

HMIs

Manufacturing historians

Job description

Orchestra BioMed is seeking an experienced Process Development Engineer to translate manual manufacturing into automation-ready processes and to scale up production. You will work on process characterization, critical parameter identification, and technology transfer with internal teams and external partners.

The role requires hands-on work on automated equipment, DOE studies, and strong documentation in a regulated development environment, with a focus on scalable, validated manufacturing