Senior Manufacturing Specialist (Biopharma)

Location: USA - NC - Durham - National Way; onsite support in a 24-hour cGMP manufacturing facility, including possible overnight, weekend, and on-call support.

Company

hirify.global operates biopharmaceutical manufacturing facilities supporting GMP production and process development.

What you will do

• Lead technical support for GMP manufacturing operations in a large-scale, multi-product facility.
• Support new product and process introductions, facility fit assessments, equipment procurement or modification, and training generation.
• Draft, route, and revise manufacturing batch records, procedures, and supporting documentation.
• Serve as a technical subject matter expert, coach manufacturing associates, and support trainer development.
• Provide process support during shop-floor execution and identify barriers and improvement opportunities with manufacturing associates and supervisors.
• Drive process improvement projects, corrective and preventive actions, deviation investigations, and operational excellence initiatives.

Requirements

• Bachelor’s degree in a related scientific or engineering discipline with 6+ years of related experience and/or training, or equivalent experience.
• Knowledge of downstream operations; experience with cell culture and/or fermentation is preferred.
• Experience with single-use platform technology is preferred.
• Ability to work with minimal direction, manage multiple priorities, and maintain operational efficiency.
• Fluent English with excellent written and verbal communication skills required.
• Ability to work in clean-room areas and support a 24-hour manufacturing operation, including possible overnight, weekend, and on-call work.

Culture & Benefits

• Work in a cGMP biotechnology manufacturing environment with office and clean-room activities.
• Support safety, compliance, quality, Lean Manufacturing, 5S, standardization, and error-proofing initiatives.
• Work may involve mechanical, chemical, electrical, noise, and tripping or falling hazards.
• Full-time employment with an EEO/AA commitment and an emphasis on workforce diversity.