Process Engineer

Harba Solutions Limited; Indianapolis, Northern (IN, KY); Hybrid; USD 65,000 - 85,000; Full time

Job summary

Harba Solutions Limited in Indianapolis, IN seeks a Chem/Process Engineer to monitor production, support CAPA and change controls, and document batch records in a regulated environment.

You will work with Manufacturing, Quality, Regulatory, and Maintenance teams, applying Lean/Six Sigma concepts and assisting with validation activities under senior engineers. Strong communication and willingness to gown on the floor are essential.

Qualifications

• Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Pharmaceutical, or related field).
• 0–2 years of relevant experience (internships, co-ops, or entry-level roles in pharma/biotech/med device).
• Basic understanding of cGMP, FDA regulations, and pharmaceutical manufacturing processes.
• Familiarity with IQ/OQ/PQ process validation concepts and documentation practices.
• Proficiency with MS Office; familiarity with statistical analysis tools is a plus.
• Strong written and verbal communication; ability to write clear technical documentation.
• Ability to work effectively in a cross-functional, highly regulated team.
• Willingness to work on the production floor, including gowning/cleanroom protocols.

Responsibilities

• Monitor daily production processes to ensure product quality and adherence to cGMP.
• Assist root cause analysis and CAPA efforts for deviations and downtime.
• Assist in authoring/updating batch records, SOPs, and process docs.
• Support process validation activities (IQ/OQ/PQ) under guidance of senior engineers.
• Participate in Lean/Six Sigma initiatives to reduce variability and improve efficiency.
• Collect and trend production data to support performance reporting and CP studies.
• Collaborate with Manufacturing, QA, Regulatory, and Maintenance to troubleshoot issues.
• Support equipment qualification, changeover, and tech transfer for new processes.
• Ensure compliance with FDA, cGMP, and internal quality systems across activities.
• Maintain audit-ready documentation for changes, deviations, and validation
• Support audits/inspections with requested data and explanations.
• Participate in safety reviews and adhere to EHS standards on the production floor.

Skills

Cross-functional collaboration

Documentation writing

Data analysis

Quality mindset

Communication skills

Education

Bachelor's degree in Engineering

Tools

MS Office

Statistics software

Job description

Responsibilities

• Monitor daily production processes to ensure consistent product quality, yield, and adherence to cGMP standards
• Support root cause analysis and CAPA (Corrective and Preventive Action) efforts for process deviations, non-conformances, and equipment downtime
• Assist in authoring and updating batch records, SOPs, work instructions, and process documentation in compliance with regulatory requirements
• Support process validation activities, including IQ/OQ/PQ protocols and execution, under guidance of senior engineers
• Participate in continuous improvement initiatives (Lean, Six Sigma, Kaizen) to optimize process efficiency and reduce variability
• Collect, analyze, and trend production and process data to support performance reporting and process capability studies
• Collaborate with Manufacturing, Quality Assurance, Quality Control, Regulatory, and Maintenance teams to troubleshoot process issues in real time
• Support equipment qualification, changeover activities, and technology transfer for new or modified processes
• Ensure compliance with FDA regulations, cGMP, and internal quality systems throughout all process engineering activities
• Maintain accurate and audit-ready documentation for process changes, deviations, validation activities, and change controls
• Support internal and external audits/inspections by providing requested process documentation, data, and technical explanations
• Participate in safety reviews and ensure adherence to EHS standards specific to pharmaceutical manufacturing (e.g., handling of APIs, cleanroom protocols)

Qualifications

Required:

• Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Pharmaceutical, or related field)
• 0–2 years of relevant experience (internships, co-ops, or entry-level engineering roles in pharma/biotech/med device count)
• Basic understanding of cGMP, FDA regulations, and pharmaceutical manufacturing processes
• Familiarity with process validation concepts (IQ/OQ/PQ) and documentation practices
• Proficiency with MS Office (Excel, Word, PowerPoint); familiarity with statistical analysis tools a plus
• Strong written and verbal communication skills, with the ability to author clear technical 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