Lead Operator, Manufacturing
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Job Location:
Frederick, MD - USA
Monthly Salary:
$ 23 - 34
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
First Shift (Days)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob Description
As part of the Thermo Fisher Scientific team youll 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 worlds 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 CAPAs. 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 foundationideally within the life sciencespaired 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 Scientifics 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: Bachelors 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
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
