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Lyophilizer Engineer

ConfidentialPithampur, Indore

1 day ago

Job description

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.

Skills Required

lyophilization, Capa, process equipment, Pr, URS

Engineer • Pithampur, Indore