
(Apply Now) Lyophilizer Engineer
4 weeks 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.
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