HS
Equipment Validation Engineer
Accepting applicationsHarba Solutions Inc. · Indianapolis, IN
Full-Time Associate Mentorarmategan
Posted
27 May
Category
Test
Experience
Associate
Country
United States
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
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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
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