Essential Duties and Responsibilities
Under the Manufacturing Lead and / or Supervisor's direction, support manufacturing operations to meet strategic department objectives.
- Prepare cleaning and sanitizing solutions and perform daily, weekly, monthly cleaning of controlled and classified manufacturing areas.
- Replenish manufacturing components, materials, and supplies in all processing areas.
- Transport bright stock and finished product to and from staging as required according to manufacturing schedule.
- Perform equipment cleaning and preparation for sterilization.
- Operate sterilizer equipment to provide format parts for filling equipment. Clean, set up, and decontaminate material transfer isolator.
- Clean, set up, and operate component processing equipment and terminal sterilizer equipment.
- Clean, set up, and operate weighing and compounding equipment.
- Weigh APIs and excipients according to batch record instructions.
- Compound bulk drug product per standard operating procedures and batch record instructions.
- Adhere to Civica procedures and policies, conform to current good manufacturing practices and good documentation practices.
- Adhere to all safety regulations. Attend and participate in daily shift meetings to communicate events and issues to the manufacturing team.
- Perform other duties as assigned by manufacturing management.
- Overtime and weekend work may be required at times.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- High school diploma or equivalent Coursework or bachelor's degree in a Life Science discipline preferred.
- 2-3 years' Experience in a pharmaceutical or cGMP regulated environment.
- High school graduate, vocational school graduate or equivalent
- Working knowledge of Microsoft applications and SAP
- Prior production experience
- Experience working in a LEAN manufacturing environment.
- Knowledge of cGMPs and FDA policies / procedures.
Preferred skills :
- Mechanical troubleshooting (manufacturing equipment)
- Aseptic Cleaning
- Equipment change part cleaning and sterilization
- Component / commodity sterilization
- Aseptic gowning / technique
- Good documentation practices
- Good reading and writing skills, and ability to perform basic to advanced mathematical calculations.
- Ability to read, understand and follow written procedures.
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