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
Qualifications
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
