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Lead Operator, Manufacturing

ThermoFisher Scientific • Frederick, MD • 16h ago

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How you will make an impact?

The Lead Operator role serves as a key operational linchpin, driving end-to-end coordination and authorship of cGMP manufacturing batch records while overseeing problem reports and CAPA's. Additionally, the Lead Operator will ensure readiness and support both internal and external audit engagements. The position also owns the continuous optimization of Standard Operating Procedures to maintain alignment with manufacturing documentation and partners cross-functionally to execute change-control activities across designated value streams. Success in this role is underpinned by a strong scientific foundation-ideally within the life sciences-paired with exceptional communication agility, operational rigor, and a demonstrated commitment to precision and compliance excellence

What you will do?

Drive end-to-end ownership of Problem Reports across all manufacturing value streams, ensuring on-time closure of NCMs, planned/unplanned deviations, and CAPA activities.

Lead the revision and maintenance of SOPs, work instructions, and batch records to uphold documentation accuracy and compliance.

Conduct ongoing assessments of production record templates to reinforce consistency, standardization, and product quality.

Engage cross-functional stakeholders to refine and streamline manufacturing documentation templates for operational efficiency.

Partner with adjacent functions to embed robust quality and cGMP practices throughout process changes and continuous-improvement initiatives.

Champion Thermo Fisher Scientific's 4Is values as part of daily operating rhythms and team interactions.

Provide occasional on-the-floor manufacturing support to observe processes, validate documentation alignment, and strengthen operational understanding.

Education/ Experience

Required: High School Diploma or equivalent.

Preferred : Bachelor's degree in biology, chemistry, or related field.

Experience

Required: Minimum of 3+ years' experience in manufacturing, operations, production, lab setting or related field.

Preferred : Experience in an FDA regulated environment or equivalent.

Knowledge, Skills, Abilities

Deep working knowledge of cGMP principles, cleanroom regulatory expectations, and end-to-end change control methodologies.

Demonstrated ability to operate autonomously while integrating seamlessly within cross-functional team environments.

Strong self-direction with a proven track record of prioritizing workload, managing time effectively, and driving commitments to completion.

Highly organized and execution-focused, with a consistent orientation toward delivering measurable results.

Skilled communicator with clear, concise, and professional verbal and written communication capabilities.

Proficient in Microsoft Office applications, including the ability to develop data-driven reports, presentations, and graphical outputs

Compensation and Benefits

The hourly pay range estimated for this position based in Maryland is $23.04-$34.56.

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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