Process Development Engineer II - Oral Solid Dosage

BioSpace; North Chicago (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

AbbVie seeks a skilled process development professional to advance oral solid dosage form manufacturing. You will design and execute development, characterization, and scale-up studies, analyze data, and communicate results to cross-functional teams in regulated environments.

The role involves executing DOE studies, applying statistical tools, and supporting campaigns and PPQ batches on site, with emphasis on quality, GMP/GxP compliance, and comprehensive technical documentation.

Qualifications

• Bachelor's degree with 3+ years of relevant experience in engineering, pharmaceutical sciences, or related field.
• Experience supporting development or manufacturing of oral solid dosage forms (tablets and capsules).
• Knowledge of oral solid dosage form unit operations including blending, granulation, milling, compression, encapsulation, and coating.
• Experience executing laboratory studies in a regulated pharmaceutical environment.
• Working knowledge of process development, scale-up, and late-stage development activities.
• Familiarity with experimental design (DOE) and statistical data analysis.
• Experience analyzing, documenting, and communicating technical results.
• Proficiency with common data analysis and reporting tools.
• Knowledge of GMP/GxP requirements and pharmaceutical documentation practices.

Responsibilities

• Perform routine laboratory and pilot-scale activities competently and independently, generating reliable and consistent results.
• Analyze and interpret results, identifying significant trends, observations, and deviations.
• Troubleshoot experiments, instrumentation, and process-related challenges.
• Learn and apply new scientific and engineering techniques as required.
• Execute process development, characterization, and scale-up studies for oral solid dosage forms.
• Demonstrate skill in multiple techniques and appropriately modify protocols to support development objectives.
• Execute designed experiments (DOE) and apply statistical tools to support process understanding.
• Support manufacturing campaigns, scale-up activities, and PPQ batches through on-site technical support.
• Author campaign memos, technical summaries, and development documentation.
• Understand and adhere to corporate standards regarding safety, data integrity, GMP/GxP compliance, and appropriate handling of materials.

Skills

Process development

DOE (Design of Experiments)

Statistical data analysis

Data interpretation

Documentation

Education

Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, or related field

3+ years of relevant experience

Job description

AbbVie seeks a skilled process development professional to advance oral solid dosage form manufacturing. You will design and execute development, characterization, and scale-up studies, analyze data, and communicate results to cross-functional teams in regulated environments.

The role involves executing DOE studies, applying statistical tools, and supporting campaigns and PPQ batches on site, with emphasis on quality, GMP/GxP compliance, and comprehensive technical documentation.