Senior Associate Manufacturing - Electronic Batch Record Support (Multiple Positions)

Location: Holly Springs, North Carolina, United States; onsite manufacturing facility role

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

Company

hirify.global is a biotechnology company developing treatments for patients and building an advanced drug substance manufacturing facility in North Carolina.

What you will do

• Support the start-up of the hirify.global North Carolina manufacturing facility across multiple manufacturing areas.
• Generate, edit, troubleshoot, validate, and maintain electronic batch records using PAS-X (Körber).
• Support manufacturing teams with electronic batch record execution and the implementation of new MES integrations and functionality.
• Optimize electronic batch records to improve functionality and align with process requirements.
• Track EBR metrics and contribute to Lean Transformation and continuous improvement initiatives.
• Support SOP creation, job aids, work instructions, staff training, and projects introducing new products and manufacturing technologies.

Requirements

• High school diploma/GED with 4 years of manufacturing or operations experience; or an associate’s degree with 2 years of experience; or a bachelor’s degree with 6 months of experience; or a master’s degree.
• Experience or knowledge in biotechnology, pharmaceutical manufacturing start-up, or a cGMP-regulated environment.
• Technical understanding of upstream and/or downstream manufacturing in a biotechnology production operation.
• Experience with PAS-X (Körber) or comparable electronic batch record software, including editing and validation.
• Knowledge of electronic systems such as SAP, EBR/MES, DeltaV, and electronic quality systems.
• Strong technical verbal and written communication skills and proficiency with Microsoft Office.

Nice to have

• Completion of the NC BioWorks Certification Program.

Culture & Benefits

• Employee health and welfare benefits for staff and eligible dependents.
• Retirement and savings plans with company contributions, medical, dental, vision, life, and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time off plans and biannual company-wide shutdowns.
• Career development opportunities and flexible work models where applicable.