Job Description:
Resources to support startup efforts. Technical resource to serve as a Equipment / Mechanical Engineer in support facility startup: Media Fills, Stability batches, water runs, PV batches, general production startup. Individual should have a clear understanding of Data Integrity and Change Control requirements and a clear understanding of how to interface with and navigate equipment HMI’s, to operate, troubleshoot and improve system operation. Person will be part of a focused/autonomous team to expedite startup activities and ensure success of a manufacturing area/line/process. 3 years of pharma sterile injectables experience expected.
Resource will report into the Lead Process Eng and/or Process Eng manager at the site and will work directly with cross functional teams (automation, Ops, quality, maint, reliability, Instrumentation, Validation and MSAT), within the operations space to support technical issues, provide engineering assessments of events for process/product impact, identify and facilitate process improvements and robustness, perform data analysis for RC determination and process optimization, lead troubleshooting efforts, own and support change control, and work side by side with operations daily in support of optimization efforts for preparing the site for BAU (business as usual). BAU support will include document reviews/edits to enhance process/machine specifications, procedures, job aides, training, and improved methods of work to streamline the processes. Provide coaching and knowledge transfer to operations and maintenance personnel. Person is expected to have a strong technical understanding of relevant processes and able to understand established system matrixes for products and commodities, able to perform protocol development for engineering studies, execution of testing to define process parameters/ capability to include recipe development and parameter identification. All work to be performed according to site procedures using cGMP and good documentation practices and performed against site commitments/needs. Work will include 12 hour shift coverage working a 3-2-3 work schedule in support of multiple shifts of operations. Resource is expected to have a solid understanding of mechanical systems, system controls and instrumentation. Persons will be expected to help build knowledge management systems/engineering playbooks as well as use of OsiPi to build dashboards for their respective areas of support.
Personnel are expected to work 100% onsite and within the operations area (clean room areas, gowning required). Personnel may require Aseptic training/certification for the job role, so person must be able to work within cleanrooms for extended periods daily. Persons with technical knowledge and understanding of the following processes/technologies/applications are preferred:
• TPO filling
• Commodity Washers
• Depyrogentation tunnels
• Cappers
• CIP/SIP processes
• Formulation tanks/transfer systems
• ATEC stopper processing
• Partswashers
• Autoclaves
• VHP processes (chambers/Isolators)
• OsiPi
• Batch Engines
• SCADA systems
• Production/GMP Documentation – protocol generation, SOPs, Batch Records, Training aides, GMP regulations, PDOCS, EQMS/QTS, EAMS
On-Site: Process Engineer Troubleshooting 3rd Shift (234660)
