Manufacturing Specialist I/II (Biotechnology)

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

Company

hirify.global operates a multi-product, large-scale biopharmaceutical manufacturing facility.

What you will do

• Support new product and process introductions and changes, including facility fit assessments, manufacturing record and procedure drafting, equipment procurement or modification, and training generation.
• Draft, route, and revise manufacturing batch records, procedures, and supporting records.
• Serve as a technical subject matter expert in manufacturing operations, coach manufacturing associates, and support trainers in developing training materials.
• Provide technical support during ongoing shop-floor execution and work with manufacturing associates and supervisors to identify barriers and improvement opportunities.
• Drive projects with significant process-improvement impact and lead corrective and preventive action implementations in partnership with Compliance and QA.
• Support operational excellence, safety, compliance, and quality initiatives, including error proofing, standardization, 5S, and lean manufacturing.

Requirements

• Demonstrated knowledge of downstream operations, cell culture, and/or fermentation.
• A bachelor’s degree in a related scientific or engineering discipline with 1+ year of related experience and/or training, or equivalent GMP manufacturing experience.
• Ability to execute routine tasks with minimal direction or supervision.
• Fluent English with excellent written and verbal communication skills.
• Detail orientation, good time management, customer focus, organization, and the ability to maintain operational efficiency and a positive demeanor in a fast-paced, multi-tasked environment.
• Ability to work in a cGMP clean-room environment, including wearing clean-room attire and maintaining good personal hygiene.
• Ability to support a 24-hour manufacturing facility, including possible on-call, overnight, and weekend support.

Nice to have

• Experience with single-use platform technology.

Culture & Benefits

• Full-time employment in a biotechnology manufacturing environment.
• Work includes both office areas and a moderate-to-high-noise manufacturing environment.
• Work may involve mechanical, chemical, electrical, tripping, and falling hazards.
• Operational excellence culture focused on error proofing, standardization, 5S, lean manufacturing, safety, compliance, and quality.