Validation Engineer I Provides support in performing eqpmt, facility & utility qualification activity & re-qualification activity to ensure compliance to cGMP & Amneal's qlty reqmts.
Assist in the prep'n/ execution of Installation Qualification (IQ)/ Operational Qualification (OQ)/ Performance Qualification (PQ) protocols for eqpmt, facility & utilities as well as rltd s/ware.
Help generate qualification report & help summarize the results which will be reviewed by the suprvsr.
Performs re-qualification of eqpmt, facility & utilities as req'd under suprvsn Identify deviations encountered during IQ/OQ/PQ execution & work w/ suprvsr to implmt mitigation solution.
Draft Standard Operating Procedure (SOP) for new operational eqpmt.
Supports process validation & cleaning validation by providing product contact surface area, eqpmt qualification parameter ranges & challenge tests criteria to techn'l srvc.
Works w/ eqpmt vendors to collect eqpmt manual & other req'd docs.
Closely works w/ the maintenance & facility teams to complete new eqpmt installation as per project reqmt.
Reqmts: Must have at least Bachelor's deg.
in Mechan'l Engg or rltd field. Must have completed coursework in Mfg Processes, Mechan'l Vibrations, Mechatronics & Engg Econ.
Job Loc. : Piscataway, NJ.Send resumes to:
Amneal Pharmaceuticals LLC, 1 New England Ave, Piscataway, NJ 08854.
Attn: HR Ref: # 12392
Location/Region: Piscataway, NJ (08854)