Validation Engineer/Analyst

Join AbbVie as a Validation Engineer/Analyst, where you'll play a vital role in ensuring the quality and safety of our products. As part of our dynamic team in Barceloneta, you will engage in a variety of validation projects that will enhance your skills and contribute to our mission of improving patients' lives.

As a Cleaning Validation Specialist, you will play a crucial role in coordinating cleaning validation activities aimed at ensuring compliance and quality in our pharmaceutical manufacturing processes. Your responsibilities will include preparing and executing detailed protocols and reports for cleaning development and validation, investigating deviations or discrepancies, and overseeing validation processes.Design and develop comprehensive cleaning procedures for new products and manufacturing equipment.Provide expert technical support for cleaning operations associated with the manufacturing and handling of Oral Solid Dose (OSD) products.Lead the cleaning validation program, ensuring all activities align with industry best practices.Implement effective cleaning agents and sound cleaning practices within newly constructed or refurbished manufacturing and sampling areas.Design and support the execution of cleaning strategies for product transfer and development projects, including training personnel.Investigate and conduct root cause analysis for cleaning-related incidents, deviations, and out-of-specification results.Enhance cleaning practices and oversee the introduction of “clean in place” equipment.Review and approve Manufacturing Cleaning Working Instructions and related documentation.Support periodic reviews of cleaning validation studies to ensure ongoing compliance.Ensure timely resolution of incidents and deviations related to cleaning validation exercises by issuing necessary Change Controls.Provide training for manufacturing and QC/QA teams on cleaning validation documentation and processes.