Responsible for installation, preventive and corrective maintenance of liquid injectable fill-finish and solution preparation equipment. Troubleshoot breakdowns, support equipment qualification and validation (IQ/OQ/PQ), manage spare parts and CMMS data, assist commissioning, support audits and ensure compliance with cleanroom and regulatory standards.
Job Description:
Preferred Qualification :
Technical Skills:
Responsibilities:
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
- 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:
- Perform routine and preventive maintenance on Fill finished lines Li k e: 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.
- Should have Knowledge on Installation, Operation and Maintenance of upstream 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:
- 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
Cmms,Iq/Oq/Pq,Urs,Fat,Sat,Dq,Clean Room Requirements,Vial Washer,Tunnel,Filling And Capping Equipment,Solution Preparation Equipment,Instrumentation Systems,Upstream Equipment
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