Manufacturing Sterile Operator PDS

JOB DESCRIPTION

Work Schedule

Rotational days/weekends

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

• Operate production equipment in accordance with the instructions detailed in the approved Batch Record and applicable Standard Operating Procedures (SOPs).
• Accurately complete, review, and verify Batch Records and departmental documentation related to assigned activities, including the execution of reconciliation calculations as defined by company procedures.
• Perform weighing operations for active pharmaceutical ingredients (APIs) and excipients in compliance with Batch Records and current SOPs applicable to the relevant production area.
• Prepare solutions intended for filling operations in accordance with approved Batch Records and applicable SOPs.
• Conduct environmental monitoring and control activities as required by Batch Records and current SOPs.
• Set up and prepare the isolator containing the filling line, ensuring that all materials comply with Batch Record requirements and checklists prepared in accordance with relevant SOPs.
• Perform filter integrity testing following the instructions specified in Batch Records and applicable SOPs.
• Load and unload lyophilizers during production activities in compliance with current SOPs.
• Operate autoclaves for terminal sterilization of products in accordance with Batch Records and applicable SOPs.
• Perform cleaning and sanitization of production equipment upon completion of manufacturing activities, following the requirements defined in Batch Records and current SOPs.
• Ensure the cleaning and maintenance of production areas at the end of manufacturing activities in compliance with applicable SOPs and GMP requirements.