Job Description
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. Work Schedule 8AM to 5PM core hours, additional hours as required. A Day in the Life 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 TrackWise 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.
Education / Experience
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. Key Duties & Responsibilities General Responsibilities 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 TrackWise. Troubleshoot packaging and labeling equipment issues and escalate 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. Basic Minimum Qualifications 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 TrackWise 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 Operations, Project Management, QA, and Facilities Management activities. Effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to define problems, collect data, establish facts, and draw valid conclusions. Work Conditions / Physical Requirements 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. May push/pull 600 lb liquid nitrogen dewars and work from a platform ladder. Must use personal protective equipment and adhere to safety protocols. Must be able to lift and carry up to 50 lbs and push up to 70 lbs. 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. 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. 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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
