Careers

Careers

We hire highly experienced individuals with several years’ experience in the industry. We create right opportunities for our employees based on their skill set, background and career goals. We provide our employees freedom to define his or her career path and support their initiative & drive. With global work locations and unique offshore, on-site and offsite delivery capabilities, we offer challenging environment to our employees to grow and explore their skills and proficiency. Our global presence allows us to diversify our team with people from multiple nationalities and cultures.

Current Openings:

Validation Engineer, Austin, TX

(E-CQR, Inc. has multiple openings in Austin, TX) Validation Engineer: Develop, review, and execute Validation protocols (IQ OQ PQ), change controls, and technical documentation. Perform computer system validation in compliance with FDA 21 CFR part11, CGMP and GxP regulations. Perform risk assessments to identify the risks and draft corrective actions and preventive actions for the Validation projects. Develop and maintain test plans, test scripts and user acceptance tests. Manage the execution of test plans. Perform backend database testing using SQL and PL/SQL scripts to query the data migration between the source and target systems. Generate various validation life cycle deliverables (e.g., URS, SRS, FRS, DDS, Validation Plans, IQ OQ PQ Test Plans, RTM, User Acceptance testing, Validation Summary Reports). Will work in various unanticipated locations throughout the U.S. Requires Master’s in Computer Science, Engineering, or related and 1 year experience. Send resume to hr@ecqrinc.com.

Manufacturing Engineer, Austin, TX

(E-CQR, Inc. has multiple openings in Austin, TX) Senior Manufacturing Engineer: Oversee and guide validation activities including Installation Qualification, Operational Qualification, Performance Qualification, and Verification run. Lead data analysis for capability factors and establish normality, transformation, etc. Perform final review and issue final approval to Manufacturing Instructions, Inspection criteria, Work Instruction. Oversee validation plans and root cause analysis, PFMEA, and coordinate the development of Design Input, Output, verification, and Validation plans for Design Function. Coordinate the development and execution of Verification and Validation protocols based on system requirements. Oversee and guide the development and initiation of sampling procedures and statistical process control methods. Responsible for performing Equipment Validation and Qualification (IQ, OQ and PQ). Perform final review and issue final approval of periodic quality reports to support quality, operations, and engineering functions. Oversee complaints analysis and the updating of deviation reports. Apply independent, technical and procedural knowledge to ensure that systems meet company standards and project requirements. Will work in various unanticipated locations throughout the U.S. Requires Master’s in Computer Science, Engineering, or related and 1 year experience. Send resume to hr@ecqrinc.com.