Location

7305 Executive Way Frederick, MD

Shift Information

2nd Shift - Monday - Friday (2pm-10:30pm; overtime as needed)

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.

Keys to Success:

Education

• Required: High School Diploma or equivalent experience.
• Preferred: Bachelor’s degree in biology, chemistry, or an associated area, or equivalent professional experience.

Experience

• Required: At least 2 years of experience in manufacturing, operations, production, lab environment, or a similar area.
• Preferred: Experience in an FDA regulated environment or equivalent.

Knowledge, Skills, Abilities

• 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.

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!