Senior Manufacturing Technician

About the role

Join a leading diagnostics manufacturing team dedicated to producing blood screening products that help protect patient safety worldwide. As a Manufacturing Technician – Reagent Filling, you will play a critical role in operating and troubleshooting automated filling equipment, ensuring product quality, mentoring team members, and driving continuous improvement in a highly regulated GMP environment.

Key Responsibilities

• Set up, operate, troubleshoot, and perform changeovers on automated reagent filling equipment to maximize production efficiency and minimize downtime.
• Execute manufacturing processes in compliance with cGMP requirements, SOPs, work instructions, and batch records.
• Receive, stage, verify, and manage materials required for filling operations.
• Perform in-process inspections and collect quality samples to ensure adherence to product specifications and quality standards.
• Complete, review, and maintain manufacturing documentation, including batch records, Device History Records (DHRs), ERP transactions, and quality documentation.
• Support equipment line clearances, production startup activities, and product changeovers.
• Investigate manufacturing issues, deviations, and nonconformances using root cause analysis methodologies.
• Partner with Quality, Manufacturing, and Operations teams to meet production targets and compliance requirements.
• Absorb and support FDA, ISO, customer, and internal audits by maintaining audit-ready documentation and supporting inspection activities.
• Maintain compliance with all FDA, ISO, safety, and quality system requirements.
• Monitor inventory usage and complete ERP-based inventory transactions.
• Apply Lean Manufacturing and 5S principles to improve safety, quality, and operational performance.
• Train and mentor junior technicians, serving as a subject matter expert for reagent filling processes and equipment.
• Identify and implement process improvements that enhance throughput, reliability, and product quality.
• Maintain compliance with all FDA, ISO, safety, and quality system requirements.
• Work effectively within cleanroom and laboratory environments while following strict cleanliness and documentation standards.

Required Qualifications

• 3+ years of experience in a GMP-regulated manufacturing environment, preferably within diagnostics, biotechnology, pharmaceuticals, or medical devices.
• Hands-on experience operating and troubleshooting automated production or filling equipment.
• Strong understanding of cGMPs, SOPs, batch records, and Good Documentation Practices (GDP).
• Experience completing and reviewing manufacturing documentation, including Device History Records (DHRs).
• Proficiency with ERP systems and electronic manufacturing systems.
• Experience supporting quality investigations, deviations, CAPAs, or root cause analysis activities.
• Able to follow detailed procedures with exceptional accuracy and attention to detail.
• Strong communication, problem-solving, and organizational skills.
• Able to work independently while collaborating effectively within cross-functional teams.

Preferred Qualifications

• Experience in blood screening, diagnostics, reagent manufacturing, or medical device production.
• Familiarity with audit readiness and participation in FDA, ISO, or customer audits.
• Experience working with temperature-sensitive materials and controlled manufacturing processes.
• Knowledge of Lean Manufacturing, 5S, and continuous improvement methodologies.
• Previous experience training, coaching, or mentoring manufacturing personnel.
• Associate’s or Bachelor’s degree in a scientific, technical, or engineering discipline preferred.