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)

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