Senior Packaging Labeling Technician

Work Schedule

Standard (Mon-Fri)

• Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers
  -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Warehouse

As a Senior Packaging and Labeling Technician on our Frederick team, you will serve as a senior-level packaging and labeling professional responsible for leading commercial packaging and labeling operations, supporting operational readiness, and ensuring compliance with manufacturing and regulatory standards. This role is expected to provide leadership and guidance within the commercial pack and label team, oversee complex batch record execution, support deviation and Track Wise activities, and act as a subject matter resource during packaging and labeling operations.

• 8AM to 5PM core hours, additional hours as required.

• Perform daily manual packaging and labeling of pharmaceutical clinical trial and commercial products.
• Daily manual packaging and labeling pharmaceutical treatments in
  -80°C and LN2 temperatures while minimizing time out of environment.
• Support Track Wise activities including deviations, investigations, CAPAs, and change controls.
• Serve as a senior team resource by mentoring junior technicians and supporting operational troubleshooting.
• Coordinate with project managers and cross-functional teams to resolve operational issues and maintain production schedules.
• Ensure inventory accuracy and accountability before, during, and after job execution.

• Requires a High School diploma or equivalent;
  Associate or Bachelor degree in a science-related field preferred.
• Minimum of 3 years of experience in manufacturing, packaging, production, pharmaceutical operations, or related industry.
• Experience working in the pharmaceutical, biotechnology, cell therapy, or food and beverage industry.
• Experience supporting commercial packaging and labeling operations.

• Act as a senior/lead technician within the commercial packaging and labeling group by providing guidance, training support, and operational oversight to junior team members.
• Oversee batch record runs and verify completion accuracy to ensure compliance with Good Documentation Practices (GDP), ALCOA principles, SOPs, and client requirements.
• Review Master Production Records (MPRs) and supporting documentation for accuracy, completeness, and compliance prior to execution and product release activities.
• Accurately complete and review batch records, ensuring documentation integrity and regulatory compliance.
• Accept/reject product to ensure materials meet acceptability and quality standards.
• Accurately count and prepare product to ensure accurate inventory before and after the completion of each job order.
• Perform line clearances, material reconciliation, and inventory accountability activities.
• Support operational readiness activities for commercial and clinical packaging campaigns.
  
  Respond to emails and inquiries related to commercial packaging and labeling operations.
• Have a knowledge of and support /or lead deviation investigations, CAPAs, change controls, and non-conformance documentation using Track Wise.
• Troubleshoot packaging and labeling equipment issues and elevate concerns appropriately to minimize operational downtime.
• Support basic equipment setup, operation, adjustment, and troubleshooting activities related to commercial packaging and labeling processes.
• Timely complete training on operating requirements, procedures, and compliance standards.
• Interact effectively with multiple functional areas including Management, Quality Assurance, Client Services, Shipping, Engineering, Validation, and IT.
• Follow all applicable SOPs, GMP, GDP, and company policies.
• Role model behaviors consistent with Thermo Fisher Scientific values and leadership expectations.

The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.

• Communicate effectively verbally and in written form.
• Strong organizational skills and the ability to prioritize work in a fast-paced GMP environment.
• Ability to prepare reports and utilize Microsoft Office applications including Excel, Word, and PowerPoint.
• Knowledge of pharmaceutical packaging, labeling, batch record documentation, and GDP requirements.
• Have a working knowledge of Track Wise or comparable quality management systems.
• Working knowledge of packaging and labeling equipment operations and troubleshooting techniques.
• Ability to work with methods to handle, process, and store specimens.
• Knowledge of Universal Precautions, general laboratory practices, and quality assurance/control.
• Ability to multi-task across…