Manufacturing Process Engineer

2 months ago

Hyderabad, India Hetero Full time
Responsible for Co-coordinating with the department head for availability of

machines for Maintenance.Responsible to co-ordinate with contractors and sub-contractors for scheduling of work.Responsible for

validation activities

and Process, Utilities equipment Qualifications.Responsible to ensure that the appropriate equipment's validations are performed, recorded and reports are made available.Responsible for

Change controls, Incidents / Deviations, CAPA activities .Responsible for Executing & coordinating for equipment qualifications for

URS/DQ/IQ/OQ/PQ .Responsible for

energy saving activities .Responsible for maintaining Quality Policy.Responsible for compliance to GMP and Safety Policy.Responsible for

Data Integrity related Compliance .Major equipment experience required:

Rapid Mixer Granulators, Fluid Bed Dryers / Processors, Blenders, Compression machines

(Korsch, Killian, Sejong, Cadmach),

Coating machines

(Gansons, Solace),

Capsule filling machines

(AF90T, ZRO),

Packing line equipments

like CVC, BQS etcSpares management of Process equipment listed abovePreventive maintenance through SAP,

SAP

knowledge to handle the engineering spares and services etcHandling of

21 CFR

compliance requirements in process equipment listed above,Ensuring the work place safety, equipment level safety requirements assessment and implementationBuilding maintenance of

clean rooms , maintaining audit readiness in the processing areas

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