Senior Operations Specialist - Lean Process Leader

NCBiotech; Durham (NC); On-site; USD 96,000 - 151,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) retirement benefits

Job summary

Merck & Co., Inc. seeks a hands-on Operations professional to lead shop floor initiatives, ensure cGMP compliance, and drive continuous improvement in a high-volume vaccine/manufacturing environment.

You will write investigations, SOPs, and batch records, while coordinating with QA, tech transfer, and operations teams. You will mentor shift teams, manage corrective actions, and support regulatory inspections, with 1st shift responsibilities and domestic relocation as needed.

Qualifications

• Bachelor Degree (science/chemical, mechanical, or electrical engineering preferred)
• Bachelor of Science degree in Engineering or Science Fields strongly preferred
• Minimum five (5) years of relevant experience in manufacturing, technical, or mechanical support in a high-volume lean operation
• Technical writing experience (investigations, change requests, SOPs, batch records, protocols)
• Ability to work independently and within multi-functional teams in a fast-paced environment.

Responsibilities

• Supports end-to-end product Value Stream Map, driving production improvements and inventory management.
• Collaborates with Operations, Technology and Quality to author regulatory observation responses and remediation projects.
• Provides leadership to production floor and may lead during manager absence.
• Acts as liaison between team and support groups for projects including tech transfers.
• Authors and owns execution of Operations protocols and corrective actions.
• Revises Standard Operating Procedures and supports internal/external inspections.

Skills

Analytical Problem Solving

cGMP Compliance

Collaboration

Competency Management

Corrective Action Management

Data Analysis

Decision Making

Manufacturing Processes

Operations Support

Process Improvements

Production Scheduling

Regulatory Management

Root Cause Identification

Site Operations

Standard Operating Procedure (SOP)

Technical Writing

Training and Development

Vaccine Manufacturing

Working Independently

Education

Bachelor Degree in Engineering or Science

B.S. in Engineering (Chemical, Mechanical, Bio-Engineering, etc.)

Tools

Excel

Minitab

JMP

Job description

Merck & Co., Inc. seeks a hands-on Operations professional to lead shop floor initiatives, ensure cGMP compliance, and drive continuous improvement in a high-volume vaccine/manufacturing environment.

You will write investigations, SOPs, and batch records, while coordinating with QA, tech transfer, and operations teams. You will mentor shift teams, manage corrective actions, and support regulatory inspections, with 1st shift responsibilities and domestic relocation as needed.