Process Validation Engineer
Saim Technologies
Dice Job Match Score™
👤 Reviewing your profile...
Job Details
Skills
- process validation
- medical device
- diagnostics
Summary
- Develop and execute IQ/OQ/PQ protocols for critical manufacturing processes.
- Conduct process characterization using DOE, SPC, and statistical modeling.
- Perform process capability studies (Cp/Cpk) and implement corrective actions for lowcapability processes.
- Define and maintain the Process Validation Master Plan (PVMP).
- Prepare validation protocols, reports, risk assessments, PFMEAs, and process maps.
- Support pilottoproduction scaleup for new blood glucose sensor manufacturing lines.
- Optimize process parameters for yield, throughput, and quality.
- Lead rootcause analysis and CAPA activities related to process deviations or excursions.
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations.
- Support internal, external, and regulatory audits by providing process validation documentation.
- Work with Manufacturing Engineering and Operations to implement validated processes on the production floor.
- Train technicians and operators on validated processes and control plans.
- Bachelor s degree in Biomedical, Chemical, Mechanical, Industrial, or related Engineering field.
- 7+ years of experience in process validation within a medical device, diagnostics, or biosensor environment.
- Strong knowledge of DOE, SPC, statistical tools (JMP/Minitab), and validation methodologies.
- Understanding of regulated medical device manufacturing and QMS requirements.
- Experience with blood glucose sensor processes or electrochemical sensor manufacturing.
- Six Sigma Green Belt or Black Belt certification.
- Experience with automated or semiautomated process lines.
- Dice Id: 91131463
- Position Id: 9058266
- Posted 9 hours ago
Company Info
About Saim Technologies
Saim Technologies provides a variety of services related to Information Technology and out sourcing and has been recognized as a one of the emerging leader in software solutions. We provide custom software development, Staffing, Training and engineering services. We offer Enterprise level web based applications, web services, technical resources, Enterprise level database, software hosting, technical support services, routine programming, and more.
Our IT services focus on providing you with increased business performance by leveraging our technological expertise, business knowledge, process quality, and people. Our dedicated Centers of Excellence and practices around each of our service offerings enable us to continuously improve processes, retain project learning, and expand knowledge repositories to deliver consistent value.
Never miss an opportunity! Create an alert based on the job you applied for.Similar Jobs
It looks like there aren't any Similar Jobs for this job yet.
Search all similar jobs