Job Description

Essential Duties and Responsibilities Under the Manufacturing Lead and/or Supervisor's direction, support manufacturing operations to meet strategic department objectives.

·     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.

·     Clean, set up, and operate 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.

·     Clean, set up, and operate packaging equipment. 

·     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.  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 pharmaceutical manufacturing environment preferred.
•  Good reading and writing skills, and ability to perform basic to advanced mathematical calculations.
•  Ability to read, understand and follow written procedures.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate. 

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.