Quality Engineer : Validations Job in Gurnee 60031, Illinois Us
Since 1955 Nypro has been providing complex plastics manufacturing solutions to the world's most successful companies. Today we are a $1.1 billion global plastics leader serving the Healthcare, Packaging and Consumer Electronics industries, along with additional markets through our strategic companies. We have over 15,000 Nypro team members at 44 locations in 15 countries, all dedicated to satisfying our customers requirements.
As one of the largest employee-owned companies in the world, we are committed to assuring that our customers receive the attention and results they need - 24 hours a day, 7 days a week. Our people have the knowledge, creativity, expertise and, most importantly, the passion and empowerment to help you do anything with plastics.
We currently have the following opening at our Gurnee, Illinois location:
Validation Engineer
Develops and implements validation and qualification policies, procedures and protocols. Reviews and analyzes protocol data to determine if requirements are met. Prepares and submits protocol reports for internal and customer review. Champions the change control process for critical equipment and systems. Recommends corrective action where necessary and develops master validation plans.
Key Responsibilities:
§ Develops validation and qualification protocols and tracks execution of protocols in support of project timelines.
§ Reviews and analyzes protocol data to determine if requirements are met. Resolves discrepancies and deviations during protocol execution.
§ Prepares and submits protocol reports for internal and customer review and approval.
§ Coordinates and manages the validation and qualification strategy for equipment and processes.
§ Maintains and administrates the change control program for critical equipment and systems.
§ Evaluates, makes recommendations and implements improvements to the validation and qualification program as part of continual improvement activities.
§ Develops and maintains validation and qualification system level documents including master validation plans, policies and procedures.
§ Support all company safety and quality programs and initiatives.
Job Specifications:
§ BS in Engineering or Equivalent
§ 4-6 years of experience in validation or qualification in healthcare or other regulated field
§ Working knowledge of ISO 13485 and 9001, or equivalent. Knowledge of 21 CFR 820, or 21 CFR 210, 211 and Part 11, a plus
Interested candidates should send their resume via email to chicagostaffing@nypro.com .