Specialist, Engineering - Rahway, NJ
1 month ago
Job Summary
This Engineer position will provide engineering support of the Rahway NJ FLEx center primarily for non-sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences Pharm Sci Pharmaceutical Operations Engineering group Pharm Ops Engineering The FLEx facility supports the formulation and filling of clinical stability and developmental supplies for Oral Solid Dosage OSDand Inhalation products including critical program needs related to new products undergoing process development new products undergoing scaleup launch and transfer to the supply networkand existing commercial products undergoing process optimizationPrimary responsibility will be to assist maintaining all equipment in accordance with GMP and Safety requirements as well as exercising Reliability Maintenance best practices to ensure timely availability of Clinical Supplies Developmental Batches meet Clinical Development Program requirements This will require routine interaction with Partner Groups such as Facilities Management FMGWES Original Equipment Manufacturers OEM Collaborate interface with the OSD Business area ensuring manufacturing activities are not delayed
Provide engineering quality engineering QE support ensuring facilities utilities equipment maintained suitable both GMP developmental use Author review update GMP procedures documentation emphasis Qualification Validation plans annual reports supporting equip computer systems Demonstrate knowledge operation troubleshooting drive operational improvements contribute protocol development Prepare execute qualifications commissioning decommissioning activities Maintain GMP documentation applicable egGMPengineering drawings database tracking Facilitate participate Quality Notification QN reporting investigations related corrective action preventive action CAPA Support routine internal audits regulatory inspections providing timely accurate responses questions observations Facilitate equipsystem changes execute periodic reviews support Quality Management System QMS activities Provide capital project support smaller larger multidisciplinary projects Interface site engineering maintenance groups outside vendor support Support ongoing operations installation capitalfacility improvements
The FLEX Center operates two-shift schedule require coverage standard business hours
Job description
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