Quality Engineer

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Description

• We are looking for an experienced Quality Engineer with previous experience in a GMP pharmaceutical manufacturing environment to help us reach our ambitious goals.
• As the Quality Engineer, you will be responsible for supporting the QA Operations organization in reviewing and approving technical records.
• Your focus will be to support the design, construction, commissioning, qualification, and validation of the new Radioligand Therapy (RLT) Isotope Manufacturing site in Indianapolis, ensuring compliance with quality objectives and regulatory requirements.
• Act as QA contact point and subject matter expert for activities related to manufacturing and QC areas during design, construction, commissioning, qualification, and validation.
• Collaborate with the Site's Manufacturing Science and Technology (MS&T) department to review and approve qualification and validation master plans for expansion projects.
• Assist in creating and reviewing source documentation for regulatory submissions.
• Support the preparation and execution of pre-approval inspections by FDA or other health authorities.
• Under the guidance of the Quality Assurance Engineer Lead, perform triaging and initiation of events such as deviations, actions, CAPAs, etc.
• Partner with cross-functional departments during triaging processes.
• Support QA Operations as a valued business partner, fostering a culture of safety, quality, delivery to patients, cost efficiency, compliance, and data integrity.
• Engage actively in process improvement and Right First-Time initiatives.
• Ensure adherence to relevant regulations and quality standards.
• Write and review Standard Operating Procedures (SOPs).

Requirements

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