Manufacturing Specialist I/II

KBI Biopharma • Durham, NC

1d

About The Position

Provides technical support for GMP manufacturing operations in a multi-product, large-scale biopharmaceutical facility. The role supports new product and process introductions and changes, including facility fit assessments, manufacturing documentation, equipment procurement or modification, and training development. It also supports ongoing manufacturing execution, process improvement, corrective and preventive actions, operational excellence, safety, compliance, and quality activities.

The position supports a 24-hour manufacturing facility and may involve on-call phone support or overnight and weekend work. Work takes place in a cGMP biotechnology facility requiring clean-room operations and appropriate clean-room attire, as well as routinely in an office area. The manufacturing environment has moderate-to-high noise and may involve mechanical, chemical, electrical, and tripping or falling hazards.

Requirements

• Demonstrated knowledge of downstream operations, cell culture, and/or fermentation.
• Bachelor’s degree in a related scientific or engineering discipline with at least one year of related experience and/or training, or equivalent GMP manufacturing experience.
• Ability to execute routine tasks with minimal direction or supervision.
• Fluent English and excellent written and verbal communication skills.
• Detail-oriented, with good time-management skills and a customer-focused approach.
• Organized and able to focus in a fast-paced, multitasking environment while maintaining operational efficiency and a positive demeanor.
• Ability to support a 24-hour manufacturing facility, potentially including on-call phone support and overnight or weekend support.
• Ability to work in clean-room areas while wearing clean-room attire and maintaining good personal hygiene.

Nice To Haves

• Experience with single-use platform technology.
• A bachelor’s degree in a related scientific or engineering discipline.

Responsibilities

• Support new product and process introductions and changes, including facility fit activities.
• Draft, route, and revise manufacturing batch records, procedures, and supporting records.
• Support equipment procurement or modification and generate training materials.
• Serve as a technical subject matter expert in manufacturing operations, coach manufacturing associates, and support trainers in developing training records (TRNs).
• Provide manufacturing process support during ongoing shop-floor execution.
• Engage with manufacturing associates and supervisors to understand barriers to success and identify improvement opportunities.
• Drive and manage projects with significant process-improvement impact.
• Lead corrective and preventive action implementations and partner with Compliance and QA to complete deviation investigations in a timely manner.
• Support operational excellence initiatives, including error proofing, standardization, 5S, and lean manufacturing.
• Support safety initiatives and compliance and quality requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level