Manufacturing Specialist I/II
KBI Biopharma•Durham, NC
About The Position
Responsible for technical support activities for GMP Manufacturing Operations in a multi-product, large-scale biopharmaceutical facility. The role supports new product and process introductions and changes, ongoing manufacturing execution, process improvement, corrective and preventive actions, and operational excellence initiatives. It also supports safety, compliance, and quality requirements in a cGMP biotechnology facility.
Requirements
- Demonstrated knowledge of downstream operations, cell culture, and/or fermentation.
- A related scientific or engineering bachelor's degree with at least one year of related experience and/or training, or equivalent GMP manufacturing experience.
- Requires minimal direction or supervision to execute routine tasks.
- Fluent in English, with 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, multitasked environment while maintaining operational efficiency and a positive demeanor.
Nice To Haves
- Experience with single-use platform technology is preferred.
- A bachelor's degree in a related scientific or engineering discipline is preferred.
Responsibilities
- Support new product and process introductions and changes, including facility fit, 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 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 implementation of corrective and preventive actions.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
