The Biologic Operator will be assigned to daily production operating different equipment in different areas of the process, as required. Perform process tests and participate in qualification and validation activities as required. Monitor alarm systems. Assemble and inspect equipment in the manufacturing area to confirm operational status. Perform cleaning and sterilization procedures. Comply with the Good Manufacturing Practices (GMPs) and with the Standard Procedures (SOP's). Work aseptically or as required by the classification of the production area. Inform the coordinator/supervisor about any event that occurred during the work shift. Review documentation ensuring that it is correct and complete.

Responsibilities

• Assure compliance with applicable Plant, Division, Corporate and Government Regulatory Agencies and cGMP practices.
• Conduct equipment and facility inspections and inform to correct situations that affect the operating and environmental conditions for people and equipment. Provide technical assistance to the manufacturing areas, specifically the troubleshooting support of the manufacturing equipment and process events.
• Receive, inspect and verify materials availability to be used for the production activities.
• Accountable of the execution, audit and timely correction of the manufacturing electronic or paper batch record discrepancies.
• Conduct cleaning operations according to the established procedures.
• Document the process and equipment status in the area electronic or manual log books.
• Verify the documentation of executed operations during the shift and document any discrepancy or event occurred during the shift through the different computerized or manual systems.
• Monitor the process critical parameters and acknowledge any deviation that could represent an issue and inform the area supervisor to take immediate actions.
• Assure that the required process sampling are taken and submitted to the Laboratory as required by the process.
• Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

• High School or GED with two (2) years of experience in the chemical, biologic, pharmaceutical or medical devices industry.
• Associate Degree in Sciences, preferably in Chemistry, Biology, Microbiology, or Associate Degree in Instrumentation, Automation, Electronics, Mechanics, Business Administration with (0) years of experience in the chemical, biologic, pharmaceutical or medical devices industry.
• Basic knowledge of laboratory techniques.
• Basic knowledge of computerized systems such as Delta V, MES and SAP preferred.
• Basic mechanical and mathematical skills.
• Basic verbal and written communication skills in English and Spanish.