Senior Specialist, Operations

As part of our Vaccine Manufacturing Organization, the Durham team is seeking a highly motivated Senior Operations Specialist to support the Operations Manufacturing Support team. This role requires the ability to work efficiently in a fast-paced environment, distill complex data into actionable insights, and demonstrate strong problem-solving and leadership skills. The position involves collaboration with internal and external stakeholders to drive initiatives, ensure sterility assurance, and implement corrective actions.

Responsibilities

• Supports the end-to-end product Value Stream Map, driving production improvements, inventory management, cost reductions, and standard work at the shop floor level.
• Collaborates with Operations, Technology, and Quality to author regulatory inspection observation responses and completes remediation projects as required.
• Assists shift managers in providing leadership to the production floor and serves as primary leadership during extended manager absences (e.g., vacations).
• Acts as a liaison between the team and support groups to resolve day-to-day issues and support projects, including tech transfer of new products.
• Authors and executes Operations protocols, corrective actions, and Standard Operating Procedures (SOPs).
• Supports internal and external regulatory inspections, presenting on topics as needed.
• Manages Operations batch record review within established timelines for release and liaises with Quality to resolve comments promptly.
• Serves as the day-shift Operations representative for site needs (e.g., Quality Assessments, Process Simulation support).
• Leads or supports production and quality projects, process system improvements, and problem-solving for real-time shop floor issues.
• Investigates process deviation events and provides expertise to the production floor on safety, compliance, equipment, and regulatory requirements.
• Works independently, balances shifting priorities, and operates with minimal manager direction in uncertain situations.
• May work on shift directly with an Operations team for shop floor support as needed.

Requirements

Minimum five (5) years of relevant experience in a manufacturing, technical, or mechanical support role in a high-volume lean operation. Technical writing experience (e.g., investigations, change requests, SOPs, batch records, protocols) is required. Must be able to work both independently and within multi-functional teams in a fast-paced environment.

Qualifications

• Bachelor’s degree (science, chemical, mechanical, or electrical engineering preferred). A Bachelor of Science (B.S.) in Engineering (e.g., Chemical, Mechanical, Bio-Engineering, Bio-Medical, Industrial) or Science (e.g., Chemistry, Biology, Microbiology) is strongly preferred.
• Sterile manufacturing shop floor experience is highly preferred.
• Working knowledge of cGMPs and regulatory requirements in the vaccine/pharmaceutical industry.
• Experience with formal problem-solving techniques (e.g., root cause analysis, Lean Six Sigma tools).
• Experience with inventory management and maintenance planning software (MRP/ERP, e.g., SAP), automated control systems, and electronic batch record systems.
• Experience managing metrics and scorecards in a business environment.
• Experience presenting to internal or regulatory auditors.
• Advanced knowledge of Excel, Minitab, JMP, and/or statistical analysis.
• Six Sigma certification is a plus.

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) Development
• Technical Writing
• Training and Development
• Vaccine Manufacturing
• Working Independently

Pay

The salary range for this role is $96,200.00 - $151,400.00. An employee’s position within the range will be based on factors including education, qualifications, certifications, experience, skills, geographic location, and business needs. The successful candidate may also be eligible for annual bonus and long-term incentives, if applicable.

Benefits

• Comprehensive medical, dental, and vision healthcare for employee and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate, and sick days.

Schedule

This is a day-shift role (1st shift). The position may occasionally require working directly on shift with an Operations team for shop floor support.