Manufacturing Operator I

Role Summary

Operate manufacturing equipment to achieve production goals at the Durham, NC facility. You will set up, operate, monitor, and control equipment and processes, read and follow SOPs and job instructions, and support production, quality, and safety objectives. This role reports to the Shift Manager.

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

• Required: High School Diploma or Equivalent
• Preferred: Associate’s Degree or Bioworks Certification
• Preferred: Minimum of one (1) year of experience in pharmaceutical solid dose manufacturing or other FDA regulated industry
• Required: 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
• Preferred: Basic mechanical skills

Additional Requirements

• Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions
• Routinely operates & inspects manufacturing equipment using hands
• Strap & unstrap pallets using hands
• Must be able to be on your feet for up to a 12-hour shift
• May require corrected vision to 20/20 or 20/25 based on role
• May require color vision based on role
• Occasionally ascends/descends a ladder; may be required to work at elevated heights
• Occasionally works around odorous &/or hazardous materials; may require latex gloves
• May perform critical job functions in extremely cold work environments depending on site
• May position oneself within confined spaces for inspection if required of the role
• Ability to work in loud noise environments with hearing protection
• May be required to secure a motorized vehicle license & operate a motorized vehicle depending on the role