What are the responsibilities and job description for the Senior Process Engineer position at United Pharma?
Hiring Senior Process Engineer Medical Devices
Location: Texas
Employment Type: W2 Only No C2C
We are seeking a Senior Process Engineer with 8 plus years of experience in the medical device industry. This role is responsible for developing optimizing and sustaining manufacturing processes to ensure high quality efficiency and regulatory compliance within a GMP regulated environment.
Key Responsibilities:
Develop and optimize manufacturing processes to improve yield efficiency and product quality
Troubleshoot and resolve process related issues on the production floor
Lead process validation activities including IQ OQ PQ and process characterization
Support new product introduction and technology transfer from R and D to manufacturing
Implement continuous improvement initiatives using lean and six sigma methodologies
Collaborate with cross functional teams including manufacturing quality and engineering
Ensure compliance with FDA ISO 13485 and GMP standards
Prepare and maintain process documentation including SOPs protocols and reports
Requirements:
Bachelor’s degree in Engineering or related field
8 plus years of experience in process engineering within the medical device industry
Strong understanding of manufacturing processes validation and GMP environment
Experience with process validation tools and continuous improvement methodologies
Excellent problem solving communication and documentation skills