Visual Inspections Engineer Role
We are seeking a Visual Inspections Engineer to support our manufacturing operation. This person will be responsible for contributing to the development and implementation of strategies to ensure high-quality products.
Key Responsibilities:
* Support Visual Inspection operations in line with all safety, regulatory, and organizational requirements.
* Develop and modify procedures as needed to support the manufacturing operation.
* Participate in process, equipment, and facilities validations efforts and project implementations.
* Review and approve process-related commissioning, qualification, and validation protocols for completeness and accuracy.
* Execute protocols in a timely manner to meet project schedule requirements.
* Lead Process Failure Mode and Effects Analysis (FMEA) for Visual Inspection.
* Establish, lead, and optimize processes for technician certification and visual inspection.
* Maintain a defect library and establish processes for trending visual inspection defects.
* Ensure alignment of site Visual Inspection procedures with global guidance documents and regulatory requirements.
* Provide technical input to guide the development of Standard Operating Procedures (SOPs) for Visual Inspection.
* Lead manufacturing and validation activities during project lifecycle.
* Collaborate with internal and external stakeholders for particle/defect evaluation.
* SUPPORT technical transfers for future product introductions.
* Investigate process exceptions or malfunction incidents affecting the process.
* Liaise with internal and external engineering personnel and quality personnel as required.
Requirements:
* A relevant third-level qualification in an engineering, science, or technical discipline (Degree Level or Master's preferable).
* At least three years of combined experience in Technical/Operations/Quality in a Pharmaceutical and Healthcare Organization.
* Experience in biotechnology, pharmaceutical, or healthcare plant manufacturing environments.
* Previous experience in clean utilities is desirable.
* Must have a high level of attention to detail and mental concentration to ensure accuracy and compliance at all times.
About Team Horizon
We strive for continuous improvement and innovation to improve health outcomes and people's lives. Our team culture values collaboration and excellence in delivering high-quality medicines to patients worldwide.