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: West Valley City Utah
Duration: Long Term

Position Overview

We are seeking an experienced CQV Engineer to support Commissioning Qualification and Validation (CQV) activities within a pharmaceutical biotechnology or medical device manufacturing environment. This role will focus on ensuring that manufacturing equipment utilities facilities and cleanroom systems are commissioned qualified and validated in compliance with GMP and regulatory requirements. The ideal candidate will have strong expertise in validation protocols equipment qualification regulatory compliance and cross-functional collaboration to ensure reliable and compliant manufacturing operations.

Key Responsibilities

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

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

Support commissioning and qualification of process equipment HVAC systems clean utilities and facility infrastructure.

Ensure compliance with GMP FDA ISPE ASTM and company quality standards throughout validation activities.

Prepare validation documentation technical reports summary reports and protocol deviations.

Collaborate with Engineering Manufacturing Quality Assurance Validation and Maintenance teams to support project execution.

Assist with investigations deviations CAPA change control and risk assessments related to validation activities.

Participate in equipment startup factory acceptance testing (FAT) site acceptance testing (SAT) and commissioning activities.

Maintain validation documentation and ensure all records comply with regulatory and quality system requirements.

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

Required Qualifications

Bachelors Degree in Mechanical Engineering Chemical Engineering Electrical Engineering Biomedical Engineering or a related engineering discipline.

3 years of experience in Commissioning Qualification and Validation (CQV) Validation Engineering or Equipment Qualification within pharmaceutical biotechnology or medical device manufacturing environments.

Hands-on experience developing and executing IQ OQ and PQ protocols for manufacturing equipment utilities cleanrooms and facility systems.

Strong knowledge of GMP FDA ISPE ASTM validation lifecycle and regulatory compliance requirements.

Experience with equipment commissioning facility qualification utility validation and cleanroom validation.

Familiarity with validation documentation protocol execution deviation management CAPA change control and risk assessment processes.

Experience supporting FAT SAT equipment startup and engineering project activities.

Strong technical documentation analytical troubleshooting and problem-solving skills.

Excellent communication and cross-functional collaboration skills with the ability to work effectively in a regulated manufacturing environment.

Experience working within pharmaceutical biotechnology or medical device manufacturing facilities is highly preferred.

Knowledge of computerized systems validation (CSV) process validation Lean Manufacturing or Six Sigma methodologies 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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