Work Schedule
Standard (Mon-Fri)
Environmental Conditions
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
Job Description
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 TrackWise activities, and act as a subject matter resource during packaging and labeling operations.
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8AM to 5PM core hours, additional hours as required.
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Perform daily manual packaging and labeling of pharmaceutical clinical trial and commercial products.
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Daily manual packaging and labeling pharmaceutical treatments in -80°C and LN2 temperatures while minimizing time out of environment.
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Support TrackWise activities including deviations, investigations, CAPAs, and change controls.
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Serve as a senior team resource by mentoring junior technicians and supporting operational troubleshooting.
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Coordinate with project managers and cross-functional teams to resolve operational issues and maintain production schedules.
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Ensure inventory accuracy and accountability before, during, and after job execution.
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Requires a High School diploma or equivalent; Associate or Bachelor degree in a science-related field preferred.
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Minimum of 3 years of experience in manufacturing, packaging, production, pharmaceutical operations, or related industry.
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Experience working in the pharmaceutical, biotechnology, cell therapy, or food and beverage industry.
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Experience supporting commercial packaging and labeling operations.
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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.
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Oversee batch record runs and verify completion accuracy to ensure compliance with Good Documentation Practices (GDP), ALCOA principles, SOPs, and client requirements.
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Review Master Production Records (MPRs) and supporting documentation for accuracy, completeness, and compliance prior to execution and product release activities.
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Accurately complete and review batch records, ensuring documentation integrity and regulatory compliance.
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Accept/reject product to ensure materials meet acceptability and quality standards.
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Accurately count and prepare product to ensure accurate inventory before and after the completion of each job order.
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Perform line clearances, material reconciliation, and inventory accountability activities.
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Support operational readiness activities for commercial and clinical packaging campaigns.
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Respond to emails and inquiries related to commercial packaging and labeling operations.
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Have a knowledge of and support /or lead deviation investigations, CAPAs, change controls, and non-conformance documentation using TrackWise.
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Troubleshoot packaging and labeling equipment issues and escalate concerns appropriately to minimize operational downtime.
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Support basic equipment setup, operation, adjustment, and troubleshooting activities related to commercial packaging and labeling processes.
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Timely complete training on operating requirements, procedures, and compliance standards.
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Interact effectively with multiple functional areas including Management, Quality Assurance, Client Services, Shipping, Engineering, Validation, and IT.
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Follow all applicable SOPs, GMP, GDP, and company policies.
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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.
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Communicate effectively verbally and in written form.
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Strong organizational skills and the ability to prioritize work in a fast-paced GMP environment.
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Ability to prepare reports and utilize Microsoft Office applications including Excel, Word, and PowerPoint.
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Knowledge of pharmaceutical packaging, labeling, batch record documentation, and GDP requirements.
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Have a working knowledge of TrackWise or comparable quality management systems.
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Working knowledge of packaging and labeling equipment operations and troubleshooting techniques.
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Ability to work with methods to handle, process, and store specimens.
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Knowledge of Universal Precautions, general laboratory practices, and quality assurance/control.
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Ability to multi-task across Operations, Project Management, QA, and Facilities Management activities.
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Effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
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Ability to define problems, collect data, establish facts, and draw valid conclusions.
Work Conditions / Physical Requirements
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Must have ability to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, and marked changes in temperature.
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May push/pull 600 lb liquid nitrogen dewars and work from a platform ladder.
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Must use personal protective equipment and adhere to safety protocols.
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Must be able to lift and carry up to 50 lbs and push up to 70 lbs.
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Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C) for up to 6 hours per day.
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Must have dexterity and attention to detail to manually label vials (RFT) in a cold environment that meet quality standards as laid out in batch records.
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Must be able to use a computer up to 6 hours per day.
What We Offer:
Compensation
Competitive Pay
Performance Related Bonus where eligible
Annual merit performance-based increase
Excellent Benefits
Medical benefits
Paid Time Off/Annual Leave
Employee Referral Bonus
Career Advancement Opportunities
Compensation and Benefits
The hourly pay range estimated for this position based in Maryland is $26.60–$28.10.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
