Hello,
HCPL Global Consulting & Services is a pioneering Management & IT consulting firm that enables Government, Banking, Private and Commercial Sectors to transform best practice concepts into effective organizational capabilities.
We offer and provide innovative solutions that help improve the performance of organizations and lead their business transformation.
Here is our Highly Esteemed Client requirement. Kindly respond to this requirement with your resume, contact, visa status, rate and current location info to speed up the interview process.
Job Title: Validation Engineer
Location: New Haven, CT
Position Type: FTE/Permanent
Position Summary:
Job Description:
Responsibilities:
- Ensure proper qualification and validation of suppliers and their processes, ensuring supplier meets the requirements for producing high-quality, reliable products.
- Developing and executing validation plans, conducting audits, and managing the overall PPAP process to ensure compliance with ISO 13485/ Medical standards.
- Write, review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures, standard calibration methods, standard test methods, specifications CAPAs and exception reports.
- Strong documentation skills - Accurately recording and managing validation processes in compliance with internal SOPs and external regulations.
- Review test results and measurements to identify discrepancies.
- SPC (Statistical Process Control)
- Knowledge on ISO 13485, FDA GMP, ISO 14971, FDA CFR 820
- Clean Room experience and Medical Prod MFG exp (added advantage).
Essentially:
- Minimum of 5 years of professional experience in a relevant field.
- Experience with Agile PLM and SAP or BPCS ERP systems.
- Experience with CAD model with use of Solidworks or AutoCAD.
- Experience with NPI and design transfers deliverables for injection molded components.
- Experience within highly regulated industry.
- Hands on experience within production and enterprise environment.
Please respond with the resume, contact, Visa Status, rate, and current location info to speed up the interview process. I will contact you if I need further details.
Thanks & Best Regards,
Savio Dcunha
Lead- Talent Acquisition
...@hcplglobal.com I www.hcplglobal.com
13234 Telecom Drive, Tampa, FL 33637
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