Kyria Arzuaga

Manufacturing and Process Validation Engineer with five years of experience leading equipment, process, supplier, and test-method qualification in regulated medical-device and pharmaceutical manufacturing. Proven experience developing and executing IQ/OQ/PQ protocols for automated manufacturing equipment, resolving validation deviations, analyzing process data, and coordinating cross-functional technical initiatives. Strong background in GMP, technical writing, change implementation, investigation support, operator training, and validation lifecycle management.

Process Engineer - Johnson & Johnson MedTech - San Lorenzo, PR

(2023-11)

• Led equipment and process lifecycle activities for new manufacturing equipment by authoring validation protocols, technical assessments, and qualification documentation that enabled compliant implementation.
• Directed qualification and change implementation for raw materials, developing validation deliverables and aligning Manufacturing, Quality, and Regulatory stakeholders to achieve compliant execution.
• Translated manufacturing-process data into actionable recommendations that identified performance trends, supported technical decisions, and advanced product-quality and process improvement objectives.
• Resolved validation and manufacturing issues through structured investigation, root-cause analysis, and coordinated corrective actions, helping maintain compliant execution and project momentum.
• Advanced engineering changes from assessment through implementation by coordinating technical documentation, qualification requirements, and cross-functional approvals across Manufacturing, Quality, and Regulatory teams.
• Provided technical leadership to operators and manufacturing personnel through training on qualified processes, protocol requirements, and controlled procedures, strengthening execution consistency and documentation compliance.

Manufacturing Engineer, Synergy Automation Line - Medtronic - Juncos, PR

(2022-01 - 2023-11)

• Led IQ, OQ, and PQ execution for a new automated manufacturing line, managing protocols development, deviation resolution, and final validation reporting to support production readiness.
• Executed test-method validation and process-development studies, analyzing accuracy, precision, and reliability data to confirm inspection and testing methods were suitable for manufacturing use.
• Authored SOPs and work instructions for validated manufacturing and inspection workflows, improving operator consistency, process traceability, and controlled-document readiness.

Microbiology Analyst - Bristol Myers Squibb - Manatí, PR

(2021-11 - 2022-01)

• Prepared environmental-monitoring schedules and sample labels to support timely execution of manufacturing-area sampling.
• Performed microbial isolation and Gram-staining activities to support organism characterization and identification.
• Conducted environmental-monitoring activities in support of manufacturing operations.

QA/QC Laboratory Technician - Ethicon, Johnson & Johnson Company - San Lorenzo, PR

(2019-11 - 2021-11)

• Conducted viable and nonviable environmental monitoring in aseptic manufacturing areas in accordance with approved procedures and GMP requirements.
• Authored microbiology laboratory investigation reports and supported investigations of out-of-specification or environmental-monitoring excursion results.
• Incubated samples and prepared and sterilized materials for microbiological analysis.
• Analyzed and documented results, operated laboratory equipment, and escalated out-of-specification conditions.
• Trained new hires in laboratory procedures, safety practices, and applicable specifications.
• Managed inventory of supplies and reagents required for analytical testing.

Bachelor - Biomedical Engineering - Polytechnic University of Puerto Rico (2018-08 - 2021-02)

Bachelor of Science - Biology - Interamerican University of Puerto Rico (2016-08 - 2018-05)