Pharmaceutical Operator - FFEx AP (Environmental Monitoring)

About the role

The Pharmaceutical Operator - FFEx AP (Environmental Monitoring) will assist in developing the structure to aseptically operate Formulation, Wash/Sterilization, Filling, & media preparations through documentation, start-up and validation activities for a new production facility.

Responsibilities

• Review & author Job Instructions, SOP’s & other documents
• Absorb and assist in the start-up and validation of new equipment
• Review standards to maintain aseptic areas & perform sanitizations & environmental monitoring
• Support event response planning
• Absorb and assist the maintenance team in the development of protocols for restoration of lost function, predictive & preventative maintenance
• Absorb and assist Subject Matter Experts (SMEs) in the training process of fellow employees in areas of expertise, to include learning systems & equipment outside of area of expertise
• Follow all safety & environmental requirements in the performance of duties
• Perform other duties as assigned

Qualifications

• High school diploma or equivalent required
• Minimum two (2) years of experience in an FDA regulated environment required
• Aseptic processing experience required
• Isolator experience preferred
• Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail required
• Computer literacy required
• Expertise in planning/organizing, managing execution, checking results & revising work plan preferred