Manufacturing Operator I - 2nd shift

Role Summary

Operate manufacturing equipment to achieve production goals on the 2nd shift packaging schedule. This role supports the Durham, NC Emerging Technologies – Solid Dosage Forms facility, contributing to the production of injectable and oral treatments.

Responsibilities

• Setup, operate, monitor & control equipment, systems & processes
• Clean & sanitize manufacturing, filling & packaging rooms & equipment per SOPs
• Execute production schedule to achieve production goals
• Handle labeling & components correctly; transferring, counting, FIFO, returns, etc
• Participate actively in & support event response
• Read & follow SOPs, job instructions & other documents to ensure compliance
• Identify, report & resolve quality issues
• Assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance
• Record/review production data in BPR & associated forms
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Qualifications

• High School Diploma or Equivalent required
• Associate’s Degree or Bioworks Certification preferred
• Minimum of one (1) year of experience in pharmaceutical solid dose manufacturing or other FDA regulated industry preferred
• Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail required
• Computer literacy including use of Microsoft Office suite programs required
• Basic mechanical skills preferred

Education

• High School Diploma or Equivalent required
• Associate’s Degree or Bioworks Certification preferred

Additional Requirements

• Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Requires standing for up to a 12-hour shift; may require corrected vision to 20/20 or 20/25; may require color vision; occasional ladder use; work at elevated heights; exposure to odorous &/or hazardous materials; use of latex gloves; work in extremely cold environments; confined spaces; loud environments with hearing protection; and potential motorized vehicle operation depending on role.