Process Development Engineer

Job Title : Process Development Engineer

Location : On-site, Indianapolis, IN

Experience : 3+ years

Employment Type : 12+ months contract

Job Summary :

We are looking for an experienced Process Development Engineer with a strong background in solid oral dosage form pharmaceutical manufacturing . This role is ideal for someone who enjoys combining hands-on process engineering with project execution to drive operational excellence, product quality, and regulatory compliance. The selected candidate will play a key role in supporting daily manufacturing operations while also leading or contributing to capital projects, scale-up, and process optimization initiatives across granulation, spray drying, compression, and coating areas.

Key Responsibilities :

Provide technical and engineering support for the manufacturing of solid dosage forms, ensuring safety, efficiency, and compliance with cGMP standards.

Lead or participate in process improvement, scale-up, and technology transfer projects , focusing on granulation, spray drying, tablet compression, and coating operations.

Conduct root cause investigations for process deviations or product issues, develop corrective and preventive actions (CAPA), and drive sustainable improvements.

Develop, optimize, and monitor critical process parameters (CPPs) to maintain consistent product quality and yield.

Prepare and review process-related documentation including batch records, SOPs, validation protocols / reports, and change control documentation.

Collaborate with cross-functional teams -including R&D, Quality, Validation, Maintenance, and Production-to ensure smooth execution of process validation and technology transfer activities.

Support equipment qualification and process validation for new or modified systems and processes.

Collect and analyze production data to identify trends, deviations, and opportunities for efficiency enhancement.

Ensure full compliance with all safety, environmental, and regulatory requirements within the manufacturing environment.

Contribute to continuous improvement initiatives and support site-level performance objectives.

Required Qualifications :

Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences , or a related technical discipline.

Minimum 3 years of hands-on experience in solid dosage form pharmaceutical manufacturing.

Strong working knowledge of granulation, spray drying, tablet compression, and coating processes .

Familiarity with cGMP regulations and global regulatory guidelines (FDA, EMA).

Proven experience in process troubleshooting, data analysis , and implementation of process improvements.

Excellent problem-solving, analytical, and communication skills .

Ability to work independently and effectively within cross-functional teams in a fast-paced environment.

Proficiency with process data analysis tools and process control systems is preferred.

Preferred Qualifications :

Experience with fluid bed granulation and / or spray drying systems .

Direct involvement in tablet compression and film coating process development or troubleshooting .

Exposure to process validation, scale-up, and technology transfer activities.

Familiarity with equipment qualification (IQ / OQ / PQ) and validation lifecycle documentation.