Lyophilizer Engineer

• Responsible for Operation & maintenance and daily monitoring of Utilities & Process Equipments (like Vial Line lyophilizers etc.).
• Responsible for review the daily logbooks of utility, lyophilizers and process equipment's and update all PM status label.
• Maintain the lyo related all activities Operation, Maintenance, Cleaning & Documentation.
• Maintain the lyo related all critical spares and consumable stock.
• Responsible for maintenance and troubleshooting of lyophilizer.
• Responsible for preparation of URS, PR and TR for lyophilizer etc. as per cGMP requirements.
• Responsible for preparation, Implementation and Compliance of all related SOPs.
• Responsible for preparation and handling of QMS documents (e.g. CCF, CAPA, Deviation, QRM etc.)
• Preparation of Preventive maintenance schedule of all equipments of Utilities, Process equipments etc.
• Timely execution of PM & attend all breakdown of lyophilizers, Utilities / Process / ETP equipments etc.
• Responsible for fix the color coding identification of all piping & Labeling equipment's. Fix the labels & display copy, Drawings etc.
• Responsible for preparation of documentation & execution URS/DQ/FAT/SAT/IQ/OQ/PQ/CQ etc. of all equipment's.

Desired Candidate Profile

• Candidate Should be from Pharma - injectable formulation background.
• Familiarity with pharmaceutical manufacturing processes and quality control procedures.