CATALENT PHARMA SOLUTIONS – $48,360.00/Year

CONT. FROM H 10B Calibrating freezers, refrigerators, WalkIn stability chambers and ReachIn stability chambers, ULT freezers, Hot box and warehouse. Using Validation and Commissioning experience with Single channel Epump, TOC analyzer, CIP skid, Autoclave, Incubator, stability chamber, temperature controlled chambers, and Air safe Potent hood. Working with Allen Bradley HMIPLC driven equipment including autoclave, single channel electronic pump, polarimeter, WalkIn freezer and CIP skid.br Performing work using cGMP, MHRA, DEA, 21 CFR part 820, 210 212 and FDA regulated Environment. Developing and executing IQ, OQ, PQ, VP, FR, DS, SOP, SRS, DI, FMEA, JSA, Ergonomic assessment and Lock out tag out LOTO procedure for the equipment, computerized systems, facility and utilities.br Working with biolife science, solid dosage and softgel manufacturing environment. Performing work using thermal mapping of the GMP Pilot plant, controlled cage, warehouse, WalkIn Refrigerator, WalkIn freezer, Refrigerator Freezer, stability chamber, Airhandler, HVAC system, DEA Vault and hot box. Using equipment including HEPA filter flow meter, process calibrator, kaye validator, data logger, RTD, Thermocouples and tachometer. Developing system architecture, user requirements, software requirements and IOQ protocol to validate the GAMP 5 based software packages such as Vaisala and Madge Tech. Drafting site validation plan to qualify the equipment and instruments in the facility as per the ISPE guidelines. Identifying and tracking the root cause of the issue and implementing the robost CAPA for the investigation using the Trackwise tool. Writing the CAPEx document to track the spending on the projects and to onboard new equipment. Working with CMMS platform JDE to create work order to track the calibration and preventative maintenance plan.br br Beneficiary has the equivalent of a 4 year US Bachelors degree in Mechanical Engineering from Anna University India dated 112014 by education evaluation prepared by Silvergate Evaluations dated 01152018. Beneficiary also has a US Masters degree in Mechanical Engineering from Gannon University dated 12182015. Employer acknowledges and confirms Beneficiary meets its education requirement.br br Beneficiary also meets and exceeds the employers requirement of 2 years of experience after receiving the Bachelors degree in 112014 with experience at Catalent Pharma Solutions full time40 hours per week as a Metrologist Mechanical Engineer from 02192018 to 07122020 for a total of 2 years 4 months 24 days of experience in the Related Occupation see Section H. 10B after receiving the Bachelors degree in 112014 in a position that is not substantially comparable to the job opportunity listed in Section H. Employer acknowledges and confirms Beneficiary meets and exceeds its experience requirement.