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Sr Process Engineer

Insight Global
San Diego, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

An employer is looking for a Process Engineer to join their team in San Diego, CA. The employer is an enterprise level company in the biotech industry. The Process Engineer will support the Technical Operations Team in the in vitro medical diagnostics device manufacturing setting. The ideal candidate will lead a team of engineers working on Process Improvement Projects with the goal of increasing product yield, and will design experiments to support investigations of non-conformances, process improvement, product transfers and problem-solving. The candidate will lead efforts to improve manufacturing workflows, evaluate critical attributes of key manufacturing processes, perform root cause analysis of failure modes, define specifications as well as developing implementation strategies. Additional duties include defining project scope, estimating budget and timelines, presentations in multi-functional setting.



•    Assess existing manufacturing processes and workflows

•    Design and complete process engineering experiments (including DOE) related to process and efficiency improvement

•    Develop process specifications for raw materials and manufacturing processes

•    Develop relevant data tracking and trending structures to monitor processes and discover other areas for improvement

•    Apply process simulation software to test and find the most appropriate production strategies

•    Solve technical issues through a structured RCCM process

•    Perform statistical analyses on collected datasets and employ statistics in experimental design

•    Design and conduct controlled experiments to address yield and quality issues and drive implementation of solutions in a production environment

•    Write and review manufacturing documents, standard operating procedures, technical reports, work instructions

•    Collaborate multi-functionally with R&D, Manufacturing and Quality to develop processes for new products and improve processes of existing products

•    Support the transfer technology, processes, products from Development into a regulated manufacturing environment




•    Bachelor's Degree (Preferred majors: Chemical Engineering, Electrical Engineering, Mechanical Engineering, Biomedical Engineering)

•    5+ years' experience in quality and/or process engineering

•    Experience in large scale manufacturing and design

•    Understands good laboratory practices (GLPs) and good manufacturing practices (GMPs)

•    Experience with material properties, microfluidics, lyophilization process, ultrasonic welding

•    Experience in statistical software and databases (e.g., JMP) is a plus

•    Experience in technical process safety aspects, engineering design or modelling software preferred

•    Experience in lateral flow technology is preferred

•    Experience working in a regulated environment (FDA/GMP/ISO) is preferred

•    Experience in the IVD medical device and/or biotechnology industry is preferred

•    Excellent analytical, statistical, and mathematical skills

•    Strong written and oral communication skills

•    Excellent interpersonal skills with the ability to interact with all levels of the organization both orally and in writing; consistent track record of working multi-functionally

•    Knowledge of process engineering software systems

Insight Global


San Diego, CA



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