Job Description
Job Description:
We are seeking a Manufacturing Engineer with at least 2 years of experience in a regulated manufacturing environment, preferably within the medical device industry, to support and enhance manufacturing operations with a strong focus on process validation planning and execution. This role is ideal for an engineer who already has hands-on validation experience and wants to deepen their expertise in medical device process validation while contributing to process development, improvement, and manufacturing scale-up.
Responsibilities:
+ Support and execute process validation activities in compliance with FDA regulations and internal quality requirements.
+ Participate in validation planning by assisting with strategy development, risk assessments, protocol drafting, and planning reviews.
+ Support and execute validation activities, including IQ/OQ/PQ, data collection, data analysis, and preparation of validation reports.
+ Provide a...
We are seeking a Manufacturing Engineer with at least 2 years of experience in a regulated manufacturing environment, preferably within the medical device industry, to support and enhance manufacturing operations with a strong focus on process validation planning and execution. This role is ideal for an engineer who already has hands-on validation experience and wants to deepen their expertise in medical device process validation while contributing to process development, improvement, and manufacturing scale-up.
Responsibilities:
+ Support and execute process validation activities in compliance with FDA regulations and internal quality requirements.
+ Participate in validation planning by assisting with strategy development, risk assessments, protocol drafting, and planning reviews.
+ Support and execute validation activities, including IQ/OQ/PQ, data collection, data analysis, and preparation of validation reports.
+ Provide a...