Address
Form of workThe MS&T Process Engineering team istasked with improving the maturity, scale, and efficiency of manufacturing processes;driving key initiatives that include capacity expansion, process scale-up andTech Transfers activities.
The Sr. Engineer will work with Scientists and Specialists within MS&T,partnering cross-functionally with Quality, Production and other engineeringgroups to develop processes for new products and sustain and improve processesfor existing products within any one of the following Manufacturing areas:Fermentation, Purification, Bulk Fill or Technical Services.
Initiate and lead process equipment improvements, onboarding and purchase ofnew equipment.
Prepares equipment related operating procedures and/or relevant engineeringdocuments (SOPs, protocols & reports for FATs, comparability, manufacturingprocess validation testing), including data interpretation and able tocommunicate technical results in cross-functional settings.
Coordinating vendor visits for onsite service, work with instrumentation groupfor other calibration events.
Participates in projects associated with process equipment, processimprovements, as well as design, start-up, commissioning, and qualification ofnew investments.
Leads technical support to commercial group for routine manufacturing processes
Provides guidance to staff with production support activities includingpre-production checks and equipment testing activities as required
Ensure successful manufacturing process comparability and process validationruns by assessing risk, setting preventative measures in place, investigating,and troubleshooting equipment/process related issues
Provide technical support for new products to site including process/equipmentfeasibility assessments, process and equipment requirements
Supports all QA Compliance investigations for process deviations, technicalassessment of issues, root cause investigations, CAPA task management
Ability to own and drive change control records as required to supportdepartmental projects and assigned CAPAs.
Ability to lead process technology transfers from other depts. to increase theeffectiveness of Manufacturing processes
Partners and collaborates with site Project Management organization as requiredwith higher level long term initiatives.
Requirements
Strong technical expertise in biotech unit operations and equipment, especiallyin the area of recombinant protein production and protein purification
Advanced working knowledge and experience in cGMP environments (understandingof equipment, technology, and quality systems requirements)
Experience with project design, construction, start-up, commissioning andvalidation as well as leading and supporting factory acceptance tests and siteacceptance
Experience with automated equipment engineering and validation
May be required to work periodically out of normal business hours
Must be self-motivated, detail-oriented, collaborative, and able to workeffectively in a fast-paced environment.
Must be able to work independently, manage multiple priorities, with theability to prioritize and complete activities on time
Demonstrated effective communication, oral and written, in amulti-disciplinary, project-driven work environment.
Attention to detail, strong organizational skills, the ability to multitask,and effective interpersonal and communication skills are required.
5S, OpEx, and Lean manufacturing experience a plus.
