TSMS Engineer
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-08-30
Listing for:
Harba
Full Time
position Listed on 2026-08-30
Job specializations:
-
Engineering
Quality Engineering, Process Engineer, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
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 (OOT) 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 critical process parameter (CPP) monitoring
- Collaborate with Manufacturing, Quality, Regulatory, and Process Engineering to support annual product reviews (APR) and continued process verification (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) related to process and product knowledge
- 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
Required:
- Bachelor's degree in Engineering (Chemical, Biomedical, Pharmaceutical, Industrial, or related field) or related science discipline
- 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
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