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

Location: Holly Springs, North Carolina, United States; on-site support for the hirify.global North Carolina manufacturing facility.

Company

hirify.global is a biotechnology company developing and manufacturing medicines, including products made at its new FleX Batch drug-substance facility.

What you will do

• Support electronic batch record generation, editing, execution, troubleshooting, and validation using PAS-X (Körber).
• Create, maintain, and optimize electronic batch records for manufacturing processes.
• Assist with new MES integrations and functionality implementation.
• Track EBR metrics and contribute to Lean Transformation and continuous improvement initiatives.
• Support SOPs, job aids, work instructions, digital manufacturing tools, and staff training.
• Participate in projects introducing new products and manufacturing technologies across dispensing, preparation, cell culture, harvest, purification, testing, and column-packing operations.

Requirements

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

Nice to have

• Completion of the NC BioWorks Certification Program.

Culture & Benefits

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