Equipment Validation Engineer

Job Overview:

We are seeking a Commissioning, Qualification & Validation (CQV) Engineer to support pharmaceutical and biotech manufacturing projects within GMP-regulated environments. This role is responsible for executing commissioning, qualification, and validation activities for manufacturing equipment, utilities, facilities, and process systems while ensuring compliance with regulatory and quality standards. The ideal candidate will contribute to validation lifecycle activities, collaborate with cross-functional teams, and support project execution from planning through completion. This is an on-site role supporting complex manufacturing operations and capital projects.

Job Responsibilities:

• Develop, execute, and review commissioning, qualification, and validation protocols for manufacturing systems and equipment
• Support validation lifecycle activities including URS, risk assessments, FAT, SAT, IQ/OQ/PQ, and summary reporting
• Execute qualification activities for facilities, utilities, process equipment, and packaging systems within GMP-regulated environments
• Document test execution results, deviations, investigations, and corrective actions in accordance with compliance standards
• Coordinate project activities with engineering teams, operations, vendors, contractors, and quality groups
• Ensure validation documentation is audit-ready and aligned with FDA, cGMP, ASTM E2500, ISPE, and industry guidelines
• Support change controls, SOP revisions, periodic reviews, and requalification activities
• Collect, review, and analyze validation data to support project deliverables and compliance initiatives
• Assist with project scheduling, resource coordination, and progress tracking to support project timelines
• Mentor junior team members and contribute to continuous improvement and knowledge-sharing initiatives

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field
• 2-5 years of experience in commissioning, qualification, validation, or related engineering activities within pharmaceutical, biotech, chemical, or regulated manufacturing environments
• Experience supporting GMP-regulated manufacturing and validation lifecycle activities
• Familiarity with FDA regulations, cGMP requirements, ASTM E2500, ISPE guidelines, and risk-based validation approaches
• Experience authoring and executing validation documentation including IQ/OQ/PQ protocols and risk assessments
• Strong technical writing, organizational, and problem-solving skills
• Ability to manage multiple priorities and communicate effectively with cross-functional teams and clients
• Experience with validation tools, temperature mapping systems, or electronic validation platforms such as Kneat, Kaye Validator, ValProbe, Ellab, or similar systems is preferred