Summary

Looking for a Senior Engineer in MS&T

·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

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.

•  US Citizen


• Green Card