Job Title:
Senior Validation Engineer

Company: EPM Scientific

Location: Minneapolis, MN

Created: 2024-05-04

Job Type: Full Time

Job Description:

EPM are seeking a Contract Validation Engineer for one of our biopharmaceutical partners that specializes in key aspects of new drug development. This role with be Hybrid; Minnetonka, MinnesotaScroll down to find an indepth overview of this job, and what is expected of candidates Make an application by clicking on the Apply button.This position leads validation and quality engineering activities for internally manufactured products, including validation plans, protocols and reports, maintenance of DMR, change control and CAPA/Deviation investigations. This position is the owner of the process validation system and is responsible for developing and maintaining procedures and policies in accordance with regulatory requirements and industry standards.Oversee validation and quality engineering for internally manufactured productsLead CAPA/NCR/SCAR investigations and reportsManage validation standard operating procedures in compliance with regulatory requirementsDevelop validation plans, protocols, and reports for assembly and packaging processesDesign for Six Sigma and Critical to Quality training and experience a plusSupport internal and external auditsExperience:5-7 years of relevant experience within the medical device industry or related functionLead auditor certification preferredBackground in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plusContract details:6 months40 hoursW2 contractAnticipated Start: ASAP