Process Engineer Visual Inspection
We are seeking an experienced Process Engineer VI to support critical Visual Inspection (VI) and Container Closure Integrity Testing (CCIT) initiatives within a GMP-regulated pharmaceutical manufacturing environment. This position will play a key role in the implementation, qualification, optimization, and lifecycle management of advanced inspection technologies used to ensure product quality, patient safety, and regulatory compliance.
The successful candidate will work across multidisciplinary teams including Engineering, Manufacturing, Quality Assurance, Validation, Automation, and Technical Operations to deliver complex projects focused on visual inspection systems, machine vision technologies, defect detection, and container closure integrity programs.
This is an excellent opportunity for an engineer with strong technical expertise in pharmaceutical manufacturing, process improvement, equipment validation, and root cause problem solving who thrives in a fast-paced production environment.
Key Responsibilities
Visual Inspection & CCIT Leadership
- Lead the implementation, qualification, and integration of new Visual Inspection and Container Closure Integrity Testing technologies across manufacturing operations.
- Support the selection, design, installation, commissioning, qualification, and validation of automated and semi-automated inspection equipment.
- Provide technical oversight for machine vision systems, automated inspection platforms, leak detection technologies, and defect classification processes.
- Evaluate current inspection and testing methodologies and drive continuous improvements to enhance reliability, efficiency, and product quality.
- Develop and execute protocols for system qualification, validation, performance verification, and requalification activities.
Process Engineering & Improvement
- Analyze process performance data to identify opportunities for optimization and increased operational efficiency.
- Reduce false reject rates and improve defect detection capability through process enhancements, equipment tuning, and data-driven decision making.
- Support troubleshooting activities related to inspection equipment, process deviations, yield losses, and manufacturing performance challenges.
- Apply Lean Manufacturing and continuous improvement principles to enhance inspection system effectiveness and throughput.
- Monitor key performance indicators and establish processes to improve operational excellence.
Validation & Compliance
- Author, review, and execute validation documentation including IQ, OQ, PQ protocols and reports.
- Ensure all activities comply with GMP requirements, internal quality standards, and applicable regulatory expectations.
- Support change controls, risk assessments, deviation investigations, CAPAs, and quality events associated with inspection and CCIT systems.
- Participate in regulatory inspections and internal audits by providing technical expertise and supporting documentation.
- Maintain data integrity and documentation practices in accordance with industry standards and company procedures.
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