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

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