Validation Engineer Warsaw, IN (Onsite) MP

Job Description

Dice is the leading career destination for tech experts at every stage of their careers. Our client, ASCII Group LLC, is seeking the following. Apply via Dice today!

Hello,

The following requirement is open with our client.

Title : Validation Engineer

Location : Warsaw, IN (Onsite)

Duration : 12+ Months

Rate :

Visa Status : H1B / TN Visa / E3.

In-Person Interview : Yes

Relevant Experience:9+

Detailed Job Description

* Develops and Executes Cleaning Validation Strategies: Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective cleaning processes for medical devices and equipment.
* Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge.
* Analyzes Data and Reports Findings: Compiles and analyzes validation data, writes comprehensive reports, and identifies trends for process improvement.
* Collaborates Cross-Functionally: Works with Manufacturing, Quality Assurance, Engineering, and other teams to implement cleaning strategies, resolve issues, and provide technical support.
* Manages and Improves Cleaning Processes: Leads continuous improvement initiatives, manages change controls, troubleshoots cleaning problems, and ensures proper documentation and training.
* Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers.
* Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc.
* Conducting feasibility study to estimate a product cost and analyze capital equipment, capacity, and capability requirements
* Establishing and improving process methods that meet performance and quality requirements
* Developing and executing project plans and schedules for work activities
* Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.
* Evaluating multiple options to select the most appropriate processes and machining methods
* Execute equipment qualification or process validation project(s)

Must Have Skills

* Validation Engineer

Certification: Nice to have.

Best,

Mohith Pothamsetti

Technical Recruiter | ASCII Group, LLC

mohith DOT pothamsetti@asciigroup DOT com

Certified MWBE | WBE | MBE | WOSB | CPUC | E-Verify employer