Manufacturing Technician

Reports to: Manufacturing  Supervisor

Department:  Manufacturing

Position Scope:

The Manufacturing Technician has primary responsible for the activities and procedures which are required to formulate and fill products. The position follows established procedures in the execution of daily activities.

Strategic Focus Areas:

  • Perform all activities within the confines of the Quality System and cGMP principles
  • Participate in projects and activities which support the growth efforts of the Company
  • Maintain cost discipline within assigned programs

Specific Tactical Responsibilities:

  • Maintain certification for aseptic gowning and demonstrate the ability to perform duties utilizing proper aseptic technique
  • Execute manufacturing directions in order to perform dissolution, reaction, filtration, formulation and fill activities for aseptic and terminally sterilized products
  • Adhere strictly to written work instructions in order to perform clean out of place, clean in place, steam in place and autoclaving of complex equipment and components
  • Perform room sanitization activities in order to maintain controlled environment conditions
  • Perform other job specific standard operating procedures that support batch record and written work instruction execution
  • Document all work activities according to Good Documentation Practices
  • Report procedural deviations and nonconformance to management
  • Participate in root cause analysis and implement corrective actions under the guidance of management
  • Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required
  • Participate in other projects as assigned

Job Complexity:

The position works on assignments that are routine in nature where cGMP experience is required in order to perform work activities.  The Manufacturing Technician normally receives little instruction on routine work and detailed instructions and training on new assignments.

Required Qualifications:

  • AS with 5+ years’ experience in cGMP manufacturing or Bachelors’ degree in Chemistry or Chemical Engineering or related field or previous relevant experience
  • The candidate must possess the ability to read, write and verbally communicate in English
  • Ability to work flexible hours to complete work activities

Desired Experience, Knowledge, and Skills:

  • 4 -6 years previous experience in commercial FDA approved manufacturing facility
  • Experience working in a clean room or using aseptic technique
  • Experience using commercial scale automated equipment
  • Experience in a results driven, team environment
  • Experience performing computerized transactions and maintaining spreadsheets are a plus

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