Specialist, Sterile Engineer

Job Description

Position Description:

Specialist, Sterile Engineer

This Sterile Pharm Operations Engineer position will provide engineering support to sterile operations at FLEx (Formulation, Laboratory & Experimentation) center in Rahway NJ under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). Engineering group is responsible to maintain process and utility equipment in a validated state and to provide reliable uninterrupted business continuity.

The FLEx sterile area supports the formulation and filling of clinical, stability, and developmental supplies for biologics and vaccines, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization. The area is currently under construction, primary responsibility will be to apply relevant experience to contribute to equipment and facility design, system commissioning/qualification, maintenance and calibration data build, as well as other GMP operational readiness critical activities to enable facility startup.

Post turn-over from project, it will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. Work collaboratively with various partner groups such as operations, equipment vendors, site maintenance, quality.

Provide quality engineering support that includes authoring and executing commissioning and qualification protocols and summary reports for utilities, process, and support equipment. Responsible to execute capital and expense equipment related projects. Provide capital project administration (processing capital requests and administering capital project closeout activities). Maintain GMP documentation where applicable, such as GMP engineering drawings, post-approved qualification documents, and equipment database tracking. Facilitate and/or participate in deviations reporting, investigations and any related corrective action/preventive action (CAPA). Facilitate equipment/system change controls, execute periodic reviews and support Quality Management System (QMS) activities. Provide technical expertise, troubleshooting and improved equipment reliability/performance. Partner with cross-functional teams to implement sterile validation program. Contribute to the planning, design, and execution of validation procedures and studies. Actively participate to achieve program deliverables.

Interface with site engineering and maintenance groups, as well as outside service providers to create maintenance and calibration data build. Establish partnership with contractors, vendors, outside service providers to manage service level agreements. Ensure appropriate equipment spare part inventories are established and maintained as required. Create and manage lockout/tagout and hazardous energy control procedures. Support mechanical aspects of clinical operations, including …