Production Associate (Pharmaceutical​/Biotech

• Support manufacturing by providing subject-matter expertise for drug product vial and syringe filling processes as production process owner (PPO)
• Lead sophisticated projects or parts of projects using project management skills.
• Resolve quick issues and execute function tests to troubleshoot and optimize process
• Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
• Own Quality Records, such as CCMS, CAPA, and CAPA-EV.
• Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.
• Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
• Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
• Demonstrate strategic problem-solving skills and champion continual improvement.
• Ability to be on-site (flexible worker)
• Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
• Develop/own drug product manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.
• Support New Product introduction and projects through SUS mapping
• Support manufacturing and quality through the SUS defect/leak triage process – perform troubleshooting on the floor, initiate investigation and bring leaks and defects to triage
• Initiate EN/SICAR records and follow process to conclusion, including working with vendors on investigation.
• Maintain up-to-date EN/SICAR/EE trackers and manage or lead small to medium projects
• Understand single-use material capabilities and user requirements for new technologies.

Basic Qualifications

• Bachelors degree and 2 years of manufacturing and operations experience Or
• Associate degree and 4 years of manufacturing and operations experience Or
• High school diploma / GED and 6 years of manufacturing and operations experience