Sr Operator Manufacturing (Fill) - 2nd Shift

Thermo Fisher Scientific • Frederick, MD

2d • Onsite

About The Position

A day in the Life: Work Order Lead: Manage & lead area-specific processes, ensuring all products meet or exceed quality specifications. Coordinate a team to complete production tasks efficiently while adhering to standard operating procedures (SOPs). Quality and Compliance: Track and uphold adherence to ISO, GMP, and FDA regulations. Carry out visual inspections, process batch records, and maintain accurate documentation according to quality system guidelines. Process Optimization: Implement process improvement initiatives using lean manufacturing principles such as Just-Do-It, 5S, and RCCM. Evaluate production processes for efficiency improvements and cost reduction. Equipment Operation: Manage a variety of automated and semi-automated liquid-handling and filling machines. Resolve equipment problems with assistance from 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: Use the E1 inventory management system to issue labor hours, complete work orders, and maintain accurate product and inventory records. Communication and Coordination: Effectively coordinate with internal teams and leadership drive completion of production schedules. Address any issues promptly and provide solutions to prevent future problems. Successfully finish Thermo Fisher Scientific training requirements on time and work according to all ISO, GMP, and FDA standards related to Frederick Site Manufacturing Operations. May be required to perform other responsibilities as needed and/or assigned.

Requirements

• High School Diploma or equivalent experience.
• At least 2 years of experience in manufacturing, operations, production, lab environment, or a similar area.
• Proven ability 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).
• Demonstrated leadership capabilities with the potential to lead teams and serves as a Subject Matter Expert for identified manufacturing processes and equipment.
• Strong problem-solving skills and the ability to lead projects of moderate complexity.
• Excellent verbal and written communication skills.
• Knowledge/experience in continuous improvement and lean manufacturing processes.

Nice To Haves

• Bachelor’s degree in biology, chemistry, or an associated area, or equivalent professional experience.
• Experience in an FDA regulated environment or equivalent.

Responsibilities

• Manage & lead area-specific processes, ensuring all products meet or exceed quality specifications.
• Coordinate a team to complete production tasks efficiently while adhering to standard operating procedures (SOPs).
• Track and uphold adherence to ISO, GMP, and FDA regulations.
• Carry out visual inspections, process batch records, and maintain accurate documentation according to quality system guidelines.
• Implement process improvement initiatives using lean manufacturing principles such as Just-Do-It, 5S, and RCCM.
• Evaluate production processes for efficiency improvements and cost reduction.
• Manage a variety of automated and semi-automated liquid-handling and filling machines.
• Resolve equipment problems with assistance from the maintenance team.
• Train new team members on technical processes and SOPs.
• Ensure all team members meet training requirements and maintain proficiency in operational procedures.
• Use the E1 inventory management system to issue labor hours, complete work orders, and maintain accurate product and inventory records.
• Effectively coordinate with internal teams and leadership drive completion of production schedules.
• Address any issues promptly and provide solutions to prevent future problems.
• Successfully finish Thermo Fisher Scientific training requirements on time and work according to all ISO, GMP, and FDA standards related to Frederick Site Manufacturing Operations.
• May be required to perform other responsibilities as needed and/or assigned.

Benefits

• We deliver market-rate salary, annual performance bonuses, health plans, and an assortment of employee benefits.
• Thermo Fisher Scientific provides employment in a dynamic, visionary company, coupled with strong career progression and development opportunities.
• We promote a stimulating company culture grounded in integrity, enthusiasm, involvement, and originality!
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees