Luis Rivera Email & Phone Number

Experienced in packaging equipment and process including serialization implementation and manufacturing process with a demonstrated history of working in the pharmaceuticals, medical device and biotechnology industry with over 20 years of experience. Skilled in Verification and Validation (V&V), Pharmaceutics, Change Control, Validation, and Serialization. Excellent professional with a Master of Manufacturing Competitiveness (Manufacturing Engineering) focused in Pharmaceutical Process from Universidad Politécnica de Puerto Rico. Self motivated, excellent team and leadership skills. Excellent communication skills. My experiences include: -- Validation and Packaging Consultant; Serialization implementation processes thru Packaging Technical Services designee to support the implementation of the systems and obtaining excellent results. Have worked with the optimization of Packaging process by packaging components harmonization to reduce changeover and packaging components utilization. Validation/qualification, equipment purchase, SOP and Batch Record generation, troubleshooting, CAPAs, cross-functional investigations, etc. -- Package Engineer; Worked with the optimization of Packaging process by evaluation of process and materials as well as support in validation/qualification,troubleshooting, CAPAs, cross-functional investigations, etc. in order to support continuous packaging activities. -- Engineering Project Coordinator; Worked with the coordination of decommissioning process and support the Facilities Activities and projects.--Technical Services Technician; validation/qualification, SOP and Batch Record generation, troubleshooting, CAPAs, cross-functional investigations, etc.

Listed skills include Capa, Change Control, Gmp, Pharmaceutical Industry, and 23 others.