Manufacturing Process Engineer – Quality & Compliance

Harba; Indianapolis (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

Harba is seeking an entry-level process engineer to support manufacturing operations in Indianapolis, Indiana. You will apply cGMP knowledge, assist with process validation, and help implement continuous improvement across production lines.

You will collaborate with Manufacturing, Quality, Regulatory, and Process Engineering to maintain data-driven control strategies and ensure product quality while supporting audits and regulatory inspections.

Qualifications

• Bachelor's degree in Engineering (Chemical/Biomedical/Pharmaceutical/Industrial) or related sciences.
• 0–2 years of relevant experience (internships, co-ops, or entry-level technical services/manufacturing sciences roles in pharma/biotech count)
• Basic understanding of cGMP, FDA regulations (21 CFR Part 210/211), and pharmaceutical process/product lifecycle
• Familiarity with process data analysis, trending, and root cause investigation methods
• Proficiency with MS Office (Excel, Word, PowerPoint); familiarity with statistical software (Minitab, JMP) a plus
• Strong written and verbal communication skills, with the ability to author clear technical reports and documentation
• Ability to work effectively in a cross-functional, highly regulated team environment
• Willingness to work on the production floor, including gowning/cleanroom protocols as required

Responsibilities

• Provide technical support and process knowledge to Manufacturing to ensure consistent, in-control production processes
• Monitor process performance data and trends to identify variability, drift, or emerging risks to product quality
• Support technology transfer activities for new products or process changes from R&D/Process Development into commercial manufacturing
• Assist in root cause investigations for process deviations, batch failures, and out-of-trend results, applying process and product knowledge
• Support authoring and execution of process validation protocols (IQ/OQ/PQ) and Process Performance Qualification (PPQ) studies
• Assist in developing and maintaining process control strategies, control plans, and CPP monitoring
• Collaborate with Manufacturing, Quality, Regulatory, and Process Engineering to support APR and CPV
• Support risk assessments (FMEA) for process changes, new equipment, or product introductions
• Assist in authoring and updating batch records, master manufacturing records, and technical reports
• Provide technical support during internal audits and external regulatory inspections (FDA, ISO)
• Participate in continuous improvement initiatives to enhance process robustness, yield, and right-first-time performance
• Ensure all technical and process documentation complies with FDA regulations, cGMP, and internal quality standards
• Maintain accurate, audit-ready documentation for process investigations, technical assessments, and validation activities

Skills

MS Office

Excel

PowerPoint

Report writing

Cross-functional collaboration

Process data analysis

Documentation

Education

Bachelor's degree in Engineering or related science

Tools

Minitab/JMP

Job description

Harba is seeking an entry-level process engineer to support manufacturing operations in Indianapolis, Indiana. You will apply cGMP knowledge, assist with process validation, and help implement continuous improvement across production lines.

You will collaborate with Manufacturing, Quality, Regulatory, and Process Engineering to maintain data-driven control strategies and ensure product quality while supporting audits and regulatory inspections.