Felipe Roldan
Senior Process Engineer II @ Takeda | Chemical Engineering, Process Engineering - Six Sigma Yellow Belt
- Role
- Senior Process Engineer Ii at Takeda
- Location
- Atlanta, GA, US
- LinkedIn followers
- 500 followers
About Felipe Roldan
Process Engineer with over 10 years of experience in sterile pharmaceutical manufacturing environments. I contribute to advancing pharmaceutical operations through process automation, vendor management, and engineering project oversight. Led initiatives that resulted in $700K for my employers, executed capital projects over $500K, and increased throughput by more than 7% through capacity modeling. Specialized in equipment validation, process troubleshooting, and deviation management under FDA, cGMP, OSHA, and EHS standards. Experienced in cross-functional leadership or projects, regulatory inspection preparation, vendor performance control, and integration of reliability improvements process operations. My role focuses on supporting critical department priorities, providing technical guidance to incoming engineers, and ensuring timely delivery of capital projects in compliance with stringent client protocols. Leveraging skills in process optimization, automation design reviews, and regulatory strategy, I aim to drive operational excellence and innovation in the biopharmaceutical sector. By collaborating with cross-functional teams and vendors, I enable safe and efficient manufacturing processes that align with my commitment to quality and patient care.
Experience
Senior Process Engineer Ii
Jan 2023 — Present · Social Circle, GA, US
Developed a Schedule Pro capacity model during a production ramp-up, improving throughput and prioritization under high-demand conditions. Train technicians and junior engineers on diagnostic protocols, reducing downtime and increasing team efficiency. Reworked legacy equipment oversight by applying change control and aligning system designs with OSHA and EHS requirements, raising compliance standards. Directed IQ/OQ/PQ validation for sterile filling and automation systems, meeting regulatory and operational readiness deadlines. Executed capital projects involving equipment upgrades, procurement, and FAT/SAT, improving equipmentreliability and process consistency. Contributed to automation design reviews and PFMEA activities during commissioning, improving reliability and reducing operational risks. Authored and followed SOPs in compliance with cGMP and validation protocols. Reviewed and supported batch record execution as part of validation and release. Experience with cleanroom operations and aseptic gowning procedures. Strengthened vendor performance by enforcing engineering change control procedures and improving documentation standards across deliverables.
Education
North Carolina State University
Bachelor's degree, Chemical and Biomanufacturing Engineering
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