Summary
Looking for a Senior Engineer in MS&T
Roles & Responsibilities
·The process engineering team is tasked with improving the maturity, scale & efficiency of manufacturing processes
·Key initiatives include: capacity expansion, process scale-up activities, site transfers, and critical pieces of new product introductions.
·Sr. Engineer will work with Scientists &Specialists within MS&T, partnering W/ R&D, Quality, Production & other engineering groups to develop processes for new products, sustain & improve processes for existing products within Manufacturing areas: Fermentation, Purification, Bulk Fill or Technical Services.
● Initiate &lead process equipment improvements, onboarding & purchase of new equipment& investigation studies. Coordinating vendor visits for onsite service, work w/instrumentation group for other calibration events.
● Leads technical support to commercial manufacturing group for routine manufacturing processes
● Evaluates new technology & implements new process equipment into GMP manufacturing
● Provides guidance to staff with production support activities including pre-production checks & equipment testing activities
● Design &execute system/equipment based studies to screen, optimize, & scale production processes, analyzes & interpret results, participate in process improvement, development, scale-up & qualification activities.
● Ability to troubleshoot new & existing product or process issues related to yield, quality & throughput, utilizing structured problem-solving techniques &quality assurance mechanisms
● Work closely with process characterization teams to assure process reliability &robustness in preparation for comparability & process validation
● Prepares equipment related operating procedures and/or relevant engineering documents(SOPs, protocols & reports for FATs, comparability, manufacturing process validation testing), including data interpretation & communication of technical results.
● Provide technical support for new products to the site including process/equipment feasibility assessments, process & equipment requirements
● Supports QA Compliance investigations for process deviations, technical assessment of issues, root cause investigations, CAPA task management
● SupportsFDA & other Regulatory inspections
● Ability to own & drive change control records for the department to support departmental projects & assigned CAPAs.
●Participates in projects associated with process equipment, process improvements, design, start-up, commissioning & qualification of new investments.
● Ability to lead process technology transfers from other depts. to increase the effectiveness of Manufacturing processes
● Partners &collaborates w/site Project Management organization with higher level, longterm initiatives
● Ensure successful manufacturing process comparability & process validation runs by assessing risk, setting preventative measures, investigating &troubleshooting equipment/process related issues
Preferred Qualifications
Minimum Qualifications
TOP5 TECHNICAL SKILL SETS REQUIRED:
1) Project management
2) Equipment onboarding, commissioning, and validation(IQ/OQ/PQ)
3) Technical writing (SOP creation)
4) Equipment troubleshooting/problem-solving.
5)Background in Mammalian cell culture familiarity with single-use bioreactors and new facility startup.
• Strong technical expertise in biotech unit operations & equipment, especially in the area of protein production & protein purification
• Advanced working knowledge & experience in cGMP environments (understanding of equipment, technology, & quality systems requirements)
• Experience with project design, construction, start-up, commissioning & validation as well as leading & supporting factory acceptance tests & site acceptance
• Experiencewith automated equipment engineering & validation
• Experiencesupporting FDA & other Regulatory inspections
• May be required to work periodically out of normal business hours
• Must be self-motivated, detail-oriented, collaborative, & able to work effectively in a fast-paced environment.
• Must be able to work independently, manage multiple priorities, with the ability to prioritize & complete activities on time
•Demonstrated effective communication, oral & written, in a multi-disciplinary,project-driven work environment.
• Attention to detail, strong organizational skills, the ability to multitask, &effective interpersonal & communication skills are required.
• 5S, OpEx, &Lean manufacturing experience a plus
OccupationalDemands:
Should be able to lift 25-50 lbs, comfortable working in GMPlab space with gowning, safety shoes, glasses, etc.
Hep B vaccine notification required.
Education:
BS in Engineering (Mechanical, Electrical, Chemical, Bioengineering) or Biology, Chemistry, or similar field. 7-10 years’ experience.
Required Skills
Work Authorization
Wabtec Corporation is a leading global provider of equipment, systems, digital solutions and value-added services for freight and transit rail....
Apply For This JobDate Posted: 2023-05-05 Country: United States of America Location: HCA09: Mission Sys (Propulsion) 3530 Branscombe Road , Fairfield, CA, 94533...
Apply For This JobDESCRIPTION Amazon operates a world-class network of delivery stations across the globe. The Amazon Logistics (AMZL) Team is responsible for...
Apply For This JobAround the globe, we help cities and industries manage, optimize and make the most of their resources. We provide an...
Apply For This JobAt Page, we promise design that makes lives better. We’re actively seeking talented people to join an empowered employee environment....
Apply For This JobWhat’s the Job? Ready to move your career forward? As a Technician at Penske, you’ll do exactly that. Here, you’ll...
Apply For This Job