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Sr Operator, Manufacturing

AT Thermo Fisher Scientific
Thermo Fisher Scientific

Sr Operator, Manufacturing

Frederick, MD

Work Schedule
First Shift (Days)

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Various outside weather conditions

Job Description

Senior Operator - Assembly Department

Job Summary:

As a Senior Operator in the Assembly Department, you will be integral in implementing work orders and enhancing the operations for, labeling, kitting, assembling, and packaging of products at Thermo Fisher Scientific. This pivotal role supports and enhances the daily production efforts, ensuring efficient operation and compliance with all regulatory standards This role demands an important level of precision and adherence to regulatory standards to ensure the production of high-quality scientific products.

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Job Responsibilities:

  • Work Order Lead: Manage & lead the filling, capping, and labeling processes, ensuring all products meet or exceed quality specifications. Be responsible for a team in completing production tasks efficiently while adhering to standard operating procedures (SOPs).
  • Quality Assurance and Compliance: Monitor and carry out compliance with ISO, GMP, and FDA standards. Perform visual inspections, lead batch records, and ensure accurate documentation as per quality system requirements.
  • Process Optimization: Implement process improvement initiatives using lean manufacturing principles such as Just-Do-It, 5S, and RCCM. Evaluate production processes for efficiency enhancements and cost reduction.
  • Equipment Operation: Operate a range of automated to semi-automated liquid-handling and filling equipment. Troubleshoot equipment issues with the support of the maintenance team.
  • Training and Development: Train new team members on technical processes and SOPs. Ensure all team members meet training requirements and maintain proficiency in operational procedures.
  • Inventory Management: Apply the E1 inventory management system to issue labor hours, complete work orders, and maintain accurate product and inventory records.
  • Communication and Coordination: effectively connect with internal teams and leadership to ensure the completion of production schedules. Address any issues promptly and provide solutions to prevent future problems.

Nature and scope:

This role is critical in supporting daily production and ensuring the efficient operation of the Fill/Finish Department. The senior operator interacts with various levels of personnel and must have excellent communication and customer service skills. The ability to recognize deviations from accepted practice is crucial, as is attention to detail to avoid errors that could impact product quality.

Minimum Qualifications:

High School Diploma or equivalent; higher education in biology, chemistry, or related field preferred.

3-5 years of related experience in a life sciences manufacturing environment.

Skills:

  • Proven record of accomplishment to follow policies and procedures independently and consistently.
  • Proficiency with Microsoft Office Suite and familiarity with ERP/MRP systems like E1 or SAP.
  • Understanding of Good Documentation Practices and experience in regulated environments (ISO 9001, ISO 13485, GMP).
  • Preferred Qualifications:
  • Demonstrated leadership capabilities with the potential to manage or lead teams.
  • Strong problem-solving skills and the ability to manage projects of moderate complexity.
  • Excellent verbal and written communication skills.
  • Knowledge and experience in continuous improvement and lean manufacturing processes.
  • Serves as an Assembly SME (Subject Matter Expert) for identified manufacturing processes and Equipment's

Physical Requirements / Work Environment

  • Ability to work in both standard and clean room environments, adhering to specific PPE requirements.
  • Flexible to work varying schedules and extended hours, as needed.
  • Capable of standing for extended periods and performing repetitive tasks.
  • Ability to regularly lift and/or move up to 25 to 50 pounds.
  • Able to properly handle and process materials that are in temperature conditions in accordance with established standard operating procedures to ensure customers receive a product that meets or exceeds quality specifications (Ambient, Cold Room (2-8), Freezer (-20), and Ultra Cold (-80).

Benefits

We offer an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career and development prospects. We offer a company culture that stands for integrity, intensity, involvement, and innovation!

Our mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain five reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values-integrity, intensity, innovation, and involvement-working together to accelerate research, solve scientific challenges, drive technological innovation, and support patients in need. Start Your Story at Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

Compensation and Benefits
The hourly pay range estimated for this position based in Maryland is $19.64-$29.46.

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

Client-provided location(s): Frederick, MD, USA
Job ID: ThermoFisher-R-01283136
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program