Manufacturing Senior Associate – Single Use Systems (SUS)

Location: On site in Holly Springs, North Carolina, United States

Salary: $86,048.05–$116,417.95 per year

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines to patients worldwide.

What you will do

• Support new product introductions and projects through single-use system mapping and drawing.
• Maintain and update single-use system standard operating procedures.
• Support manufacturing and quality teams with defect and leak triage, floor troubleshooting, investigations, and triage meetings.
• Initiate and manage Event Notification, Supplier Investigation, and Corrective Action records through resolution, collaborating with vendors.
• Maintain investigation and new-item trackers and lead small to medium-sized projects.
• Support single-use technology improvements, vendor change assessments, and continuous improvement projects involving tubing management, material kitting, and flow.

Requirements

• High school diploma/GED and 8 years of engineering or operations experience; or an associate degree and 6 years; or a bachelor's degree and 2 years; or a master's degree.
• Experience with and understanding of single-use systems.
• Experience in drug substance GMP technical support, GMP manufacturing, engineering, process development, or an equivalent area.
• Technical knowledge of drug substance processing and related disciplines.
• Ability to communicate complex technical information in presentations and technical writing.
• Experience working in a fast-paced manufacturing environment and resolving operational issues quickly.

Nice to have

• Experience coaching, mentoring, or cross-training colleagues.
• Experience leading cross-functional teams and continuous improvement initiatives.
• Data analysis or data visualization skills.
• Experience with Smartsheet, Excel, TrackWise, Veeva, Visio, or Lucidchart.
• Experience supporting manufacturing systems in 24/7 operations.

Culture & Benefits

• Employee health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plans with company contributions.
• Annual discretionary bonus program and stock-based long-term incentives.
• Paid time off and company-wide shutdowns twice a year.
• Career development opportunities and flexible work models where applicable.