Process Engineer

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 #J-18808-Ljbffr