Manufacturing Operations Specialist
Job in
Durham, Durham County, North Carolina, 27703, USA
Listed on 2026-07-18
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-07-18
Job specializations:
-
Manufacturing / Production
Pharmaceutical Manufacturing, Manufacturing & Industrial Operations, Validation Engineer
Job Description & How to Apply Below
Summary
The Manufacturing Operations Specialist supports pharmaceutical manufacturing activities by operating production equipment, executing batch records, and maintaining compliance with GMP standards while ensuring safe and efficient operations.
Roles & Responsibilities- Operate manufacturing equipment following SOPs and batch records.
- Execute manufacturing processes in accordance with GMP requirements.
- Complete electronic batch documentation accurately.
- Perform equipment cleaning and changeovers.
- Monitor production processes and identify abnormalities.
- Support deviation investigations and corrective actions.
- Maintain inventory of manufacturing supplies.
- Participate in shift handoffs and production meetings.
- Follow all safety and environmental procedures.
- Support continuous process improvement initiatives.
- 24 years of pharmaceutical or biotechnology manufacturing experience.
- Experience working in GMP-regulated facilities.
- Familiarity with electronic batch records and manufacturing systems.
- Experience operating automated manufacturing equipment.
- Associate or bachelor's degree in biology, Biotechnology, Chemistry, or related field.
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