Role Summary
The Visual Inspection Engineer supports Visual Inspection operations in compliance with all safety, regulatory, and organizational standards. The role is responsible for process optimization, validation activities, technician certification, defect management, and continuous improvement initiatives within a pharmaceutical/biotechnology manufacturing environment.
Key Responsibilities
* Work as part of the Operations team to support Visual Inspection activities in alignment with safety and regulatory requirements.
* Develop, review, and modify procedures to support manufacturing operations.
* Participate in and lead (as required) validation efforts including process, equipment, and facility qualifications.
* Review and approve commissioning, qualification, and validation protocols for completeness and accuracy.
* Execute validation protocols within established project timelines.
* Lead and participate in Process FMEAs for Visual Inspection.
* Establish, lead, and optimize the technician certification process for Visual Inspection.
* Develop and maintain the defect library.
* Establish and manage defect trending processes.
* Ensure all site Visual Inspection procedures align with Global Guidance Documents and Regulatory Requirements.
* Provide technical expertise in the development of SOPs related to Visual Inspection.
* Lead manufacturing and validation activities throughout the project lifecycle.
* Coordinate with internal and external stakeholders for defect and particle evaluations.
* Support technical transfers and new product introductions.
* Investigate process deviations, exceptions, and malfunction incidents.
* Liaise with Engineering and Quality personnel (internal and external) as required.
* Support Production to ensure processes consistently meet output and yield targets.
Essential Requirements
* Bachelor's Degree (or higher) in Engineering, Science, or a related technical discipline (Master's preferred).
* Minimum of 3 years' experience in Technical, Operations, or Quality roles within a Pharmaceutical or Healthcare organization.
* Minimum of 3 years' experience in a biotechnology, pharmaceutical, or healthcare manufacturing environment.
* Experience with: Biotechnological drug manufacturing, Parenteral manufacturing, Solution preparation, Fill-finish operations, Lyophilization, Sterilization processes
* Experience with clean utilities (desirable).
For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose