CQV Engineer

Hi,

My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a CQV Engineer position. Please send me your updated resume if you have relevant experience and are interested in this opportunity. The detailed job description is as follows.

Job Title: CQV Engineer

Location: Austin, TX

Duration: Long Term

Position Overview

We are seeking an experienced CQV Engineer to support Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical and medical device manufacturing facilities. This role will focus on equipment qualification, utility validation, process validation, and ensuring compliance with GMP, FDA, and industry regulations. The ideal candidate will have extensive experience with IQ/OQ/PQ execution, validation documentation, deviation investigations, and cross-functional collaboration throughout the validation lifecycle.

Key Responsibilities

Execute Commissioning, Qualification, and Validation (CQV) activities for manufacturing equipment, utilities, facilities, and process systems.

Develop, review, approve, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.

Perform equipment, utility, and system qualification activities in accordance with GMP, FDA, and company standards.

Support commissioning activities for new manufacturing equipment and facility expansions.

Ensure compliance with GMP, FDA regulations, cGMP guidelines, and internal quality management systems.

Analyze validation data, investigate deviations, support root cause analysis, and implement CAPA activities.

Collaborate with Engineering, Manufacturing, Validation, Quality Assurance, and Regulatory teams to ensure successful project execution.

Prepare, review, and maintain validation documentation, traceability matrices, SOPs, and technical reports.

Support internal audits, regulatory inspections, and client audits by providing validation documentation and technical expertise.

Drive continuous improvement initiatives to enhance validation processes, compliance, and operational efficiency.

Required Qualifications

Bachelor's degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, Biotechnology, Pharmaceutical Engineering, or a related engineering discipline.

5+ years of experience in Commissioning, Qualification & Validation (CQV), Equipment Qualification, or Validation Engineering within the pharmaceutical, biotechnology, or medical device industry.

Strong hands-on experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Thorough understanding of GMP, cGMP, FDA regulations, ISPE guidelines, and validation lifecycle methodologies.

Experience preparing and executing validation protocols, reports, risk assessments, and technical documentation.

Hands-on experience with equipment commissioning, qualification, and process validation activities.

Knowledge of deviation management, change control, CAPA, and quality systems.

Strong analytical, troubleshooting, documentation, and problem-solving skills.

Excellent communication and interpersonal skills with the ability to work effectively in cross-functional teams.

Experience supporting regulatory audits and inspections is preferred.

Familiarity with clean utilities, HVAC systems, computerized systems validation (CSV), cleaning validation, or facility qualification is an added advantage.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

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