Associate -engineering & Maintainance Job in Stelis Biopharma

Job Description:

Aware of GDP requirements related to Engineering.

Aware of all latest documentation standards related to regulatory requirements & audits.

Plan & work towards the target set by the management based on business needs.

Plan & work towards the individual & team goals.

Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ

Preparation of SOP, Preventive maintenance & Break down maintenance plan after receipt of work orders from end users of engineering.

Support for execution of qualification and validation activities.

Aware of all the GDP & cGMP guidelines.

Comply with the requirements of plant audits.

Involve in audits for QMS activity.

Responsible for handling of controlled documents such as SOPs, operational logbook and qualification protocol etc.,

Responsible for preparation and review of preventive maintenance and breakdown summary as per SOP.

Operation and Maintenance of lab equipments, process equipments, HVAC, gas distribution system, ETP, STP, Fire hydrant system, clean utilities, DG sets, IBR & Non IBR boilers, Chilled water plant, VRF systems etc.,

GMP documentation.

Utility block equipment operation and maintenance

Operation of fire alarm, access control, door interlock, CCTV & Fire hydrant system.

Vendor management.

External Calibration and validation of instruments planning and execution.

Inhouse preventive maintenance planning and execution.

Clean utilities like PWS, WFI & PSG operation maintenance & documentation.

Operation & maintenance of block utilities DG sets, chiller plant, boiler, transformer yard breakers.

Planning, Coordination and execution Instruments Calibration as per planner.

Prepare and maintain spare parts list of all critical equipments & instrument.

People:

• Coordination & working with CFT, external vendors, senior leadership team and reporting of activities.
• Coordination with AMC & OEM vendors for maintenance support.