Validation Engineer at QRC Group, Inc

Caguas, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

26 Dec, 25

Salary

0.0

Posted On

27 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

IQ/OQ/PQ Protocol Development, FAT/SAT Testing, Validation Master Plan Creation, MES/SCADA System Qualification, Injection Molding Validation, Automated Assembly Validation, Metrology Equipment Calibration, Gage R&R, Traceability Matrix Development, KNEAT Software, FDA 21 CFR Part 820, EU MDR 2017/745, ISO 13485, ISO 14971, GMP Compliance, Six Sigma

Industry

Staffing and Recruiting

Description

Company Description QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions! Job Description Validation Engineers to support the internal development and validation of a multi-dose preservative-free (MDPF) nozzle subsystem and any other miscellaneous project related deliverables as they arise. Scope Includes: Validation of new molding and assembly units Qualification of ISO7 clean rooms Integration of metrology instruments and handling systems Execution of IQ/OQ/PQ protocols, FAT/SAT, and traceability documentation Collaboration on a comprehensive Validation Master Plan Location: SouthEast, United States (Travel Required) Qualifications Requirements Bachelor’s in Engineering (Mechanical, Biomedical, Chemical, or Industrial) Location: SouthEast, United States (Travel Required) Technical Skills IQ/OQ/PQ protocol development and execution FAT/SAT testing and documentation Validation Master Plan (VMP) creation MES/SCADA system qualification Injection molding and automated assembly validation Metrology equipment calibration and Gage R&R Traceability Matrix development Experience with KNEAT software (highly desirable) Regulatory Knowledge FDA 21 CFR Part 820 EU MDR 2017/745 ISO 13485 & ISO 14971 GMP compliance Certifications ISO 13485 Quality Management ISO 14971 Risk Management GMP Training Six Sigma (Green or Black Belt) Soft Skills Strong documentation and report writing Cross-functional collaboration Ability to train personnel Analytical thinking and problem-solving Location: SouthEast, United States (Travel Required) Additional Information All your information will be kept confidential according to EEO guidelines.

Responsibilities

The Validation Engineer will support the internal development and validation of a multi-dose preservative-free nozzle subsystem and other project-related deliverables. Responsibilities include validation of molding and assembly units, qualification of clean rooms, and execution of various protocols.