Sr. CQV / QA Engineer

Job Description

Job Description

Job Type: Full-Time / Contract
Experience Level: Senior

Position Overview

We are looking for an experienced Sr. CQV / QA Engineer to support commissioning, qualification, validation, and quality activities within a highly regulated manufacturing environment. The ideal candidate will bring strong hands-on experience with CQV, QA, cGMP, FDA requirements, and validation documentation and be comfortable working closely with Engineering, Manufacturing, and Quality teams.

Key Responsibilities

• Lead and support Commissioning, Qualification, and Validation (CQV) activities for manufacturing equipment, facilities, utilities, systems, and processes.
• Prepare, review, and execute validation protocols, qualification documents, and final reports .
• Ensure validation activities align with cGMP, FDA regulations, and applicable industry standards .
• Partner with Engineering, Manufacturing, Quality, and other stakeholders to resolve validation and quality-related issues.
• Conduct and support risk assessments, deviation investigations, and continuous improvement initiatives .
• Maintain accurate and compliant validation records and ensure documentation is audit-ready.
• Participate in internal and external audits and assist with responses to observations and findings.
• Stay current with evolving regulatory expectations and industry best practices related to CQV and QA.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline preferred.
• 6–8+ years of hands-on CQV and/or QA experience in a regulated manufacturing environment.
• Strong understanding of cGMP, FDA regulations, validation methodologies, and quality systems .
• Demonstrated experience developing, executing, reviewing, and approving qualification and validation protocols and reports .
• Experience supporting equipment, process, facility, utility, or system qualification activities.
• Strong analytical, documentation, communication, and problem-solving skills.
• Ability to work independently while effectively collaborating with cross-functional teams in a fast-paced environment.

Preferred Experience

• Pharmaceutical, biotechnology, medical device, or other regulated manufacturing experience.
• Familiarity with risk-based validation approaches, deviation/CAPA processes, and audit readiness .
• Experience working within established quality management and validation systems.

Apply today to be considered for this senior-level CQV/QA opportunity supporting critical validation and quality initiatives within a regulated manufacturing environment.

Arthur Lawrence is a US-focused management consulting and staffing firm placing talent across IT, finance, light industries, and pharmaceuticals. We work with Fortune 500 clients and operate with a delivery-first mindset backed by a strong internal training culture.

Company Description

Arthur Lawrence is a US-focused management consulting and staffing firm placing talent across IT, finance, light industries, and pharmaceuticals. We work with Fortune 500 clients and operate with a delivery-first mindset backed by a strong internal training culture.