Responsible for installation and maintenance of liquid injectable manufacturing equipment. Collaborates with teams to ensure system reliability and regulatory compliance, performs preventive maintenance, troubleshooting, and documentation review.
- Main purpose of the Job/Role : Shall be responsible for Installation and efficient maintenance of Liquid injectable manufacturing equipment .
Preferred Qualification :
- Graduate / Diploma Engineer in Mechanical or Chemical Engineering.
- 4-6 yrs of experience in maintenance function of Liquid injectable manufacturing equipment .
Technical Skills:
- Should have Knowledge on Installation, Operation and Maintenance of Fill finished line and solution preparation equipment.
- Knowledge on qualification program (URS/FAT/SAT/DQ/IQ/OQ/PQ)
- Knowledge on operation and maintenance of respective utility / equipment / system
- Knowledge of preventive and breakdown maintenance
- Should be conversant with Validation Documents, Preventive Maintenance Schedules/Check sheets, SOP's & Various Audit Procedures
- Documentation review skills
- Knowledge on Clean room requirements and Regulatory Guidelines
- Effective problem-solving capabilities
- Excellent Interpersonal, written and communication skills
Responsibilities:
- Perform routine and preventive maintenance on Fill finished lines Like: Vial Washer, Tunnel, Filling and capping equipment and Solution preparation equipment's.
- Able to set the Fill finished line equipment's as pe the respective vial or ampoule formats changeover.
- Troubleshoot on Fill fineish lines and Solution preparation equipment's.
- Collaborate with operations and engineering teams to improve system reliability and performance.
- Ensure compliance with safety standards, industry regulations, and quality protocols.
- Assist in the installation and commissioning of new instrumentation systems.
- Participate in audits and inspections, providing technical support and documentation as needed.
- Support equipment qualification and validation processes (IQ/OQ/PQ).
- Execution of spare parts & Inventory.
- Attend to breakdowns, troubleshoot and rectify basic issues in shortest possible time and to ensure upkeep of the equipment
- Effective communication with original equipment manufacturer to address / resolve the repetitive issues.
- Prepare Equipment installation drawings and ensure the installation of the equipment as per the same
- Trend the breakdowns /concerns of the equipment and implement corrective actions to improve the reliability of the equipment.
- Review drawings issued by vendor.
- Prepare specifications for process equipment
- Complete periodic inspections of the vendors site to check for the progress of manufacturing of the equipment
- Plan and execute preventive maintenance
- Ensure that all safety instructions and measures are strictly observed
- Study and review standby facilities for critical sub-assemblies and addition of capital equipment on long term basis for smooth operation
- Prepare monthly reports
- Preparation and Review of respective Documents / Procedures
- Execution of Spare Parts management
- Supporting for the required reliability initiatives at Site
- After Completion of Preventive Maintenance and Corrective Maintenance, ensuring all the data is captured in CMMS.
- Extending required support during Walkthroughs, Internal Audits & Regulatory Audits
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Engineering
Top Skills
Fill Finished Line
Liquid Injectable Manufacturing Equipment
Solution Preparation Equipment
Validation Documents
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