CP
Validation Engineer
Accepting applicationsCommissioning Partners · Indiana, United States
Full-Time Mid_senior aiarmaterf
Posted
1d ago
Category
Test
Experience
Mid_senior
Country
United States
We are seeking a detail-oriented and motivated Validation Engineer with 2–4 years of experience to support validation activities within a GMP-regulated pharmaceutical environment. The ideal candidate will be responsible for executing equipment, process, utility, and computer system validation activities while ensuring compliance with FDA, cGMP, and company quality standards.
The Validation Engineer will work closely with Engineering, Manufacturing, Quality Assurance, and Regulatory teams to support commissioning, qualification, and validation projects for manufacturing systems and process equipment.
Responsibilities:
Support execution of validation activities including IQ, OQ, and PQ protocols for manufacturing equipment, utilities, and process systems.
Assist in commissioning and qualification activities for new and existing equipment.
Author, review, and execute validation protocols, reports, SOPs, and related documentation.
Participate in FAT and SAT activities for process and utility equipment.
Support change controls, deviations, CAPA investigations, and risk assessments related to validation activities.
Ensure validation documentation complies with FDA, cGMP, GAMP5, and company procedures.
Perform data collection, protocol execution, and validation testing activities on the manufacturing floor.
Coordinate with cross-functional teams including Engineering, QA, Manufacturing, and Maintenance to support project timelines and operational readiness.
Assist with validation lifecycle documentation including URS, FRS, traceability matrices, and validation plans.
Support audit readiness activities and provide validation documentation during internal and external audits.
Participate in continuous improvement initiatives focused on compliance, process reliability, and operational efficiency.
Required Qualifications:
Bachelor’s degree in Mechanical, Chemical, Biomedical, Electrical, or related Engineering field.
2–4 years of validation experience within pharmaceutical, biotechnology, or medical device industries.
Hands-on experience with IQ/OQ/PQ execution and validation documentation.
Knowledge of FDA regulations, cGMP, GAMP5, and 21 CFR Part 11 requirements.
Experience supporting equipment qualification, process validation, or utility system validation.
Strong documentation, troubleshooting, and communication skills.
Ability to work independently and manage multiple priorities in a fast-paced environment.
Preferred Qualifications:
Familiarity with Kneat, TrackWise, Veeva, or electronic validation systems.
Experience supporting clean utilities, process equipment, or manufacturing systems.
Understanding of risk assessments, FMEA, and change management processes.
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The Validation Engineer will work closely with Engineering, Manufacturing, Quality Assurance, and Regulatory teams to support commissioning, qualification, and validation projects for manufacturing systems and process equipment.
Responsibilities:
Support execution of validation activities including IQ, OQ, and PQ protocols for manufacturing equipment, utilities, and process systems.
Assist in commissioning and qualification activities for new and existing equipment.
Author, review, and execute validation protocols, reports, SOPs, and related documentation.
Participate in FAT and SAT activities for process and utility equipment.
Support change controls, deviations, CAPA investigations, and risk assessments related to validation activities.
Ensure validation documentation complies with FDA, cGMP, GAMP5, and company procedures.
Perform data collection, protocol execution, and validation testing activities on the manufacturing floor.
Coordinate with cross-functional teams including Engineering, QA, Manufacturing, and Maintenance to support project timelines and operational readiness.
Assist with validation lifecycle documentation including URS, FRS, traceability matrices, and validation plans.
Support audit readiness activities and provide validation documentation during internal and external audits.
Participate in continuous improvement initiatives focused on compliance, process reliability, and operational efficiency.
Required Qualifications:
Bachelor’s degree in Mechanical, Chemical, Biomedical, Electrical, or related Engineering field.
2–4 years of validation experience within pharmaceutical, biotechnology, or medical device industries.
Hands-on experience with IQ/OQ/PQ execution and validation documentation.
Knowledge of FDA regulations, cGMP, GAMP5, and 21 CFR Part 11 requirements.
Experience supporting equipment qualification, process validation, or utility system validation.
Strong documentation, troubleshooting, and communication skills.
Ability to work independently and manage multiple priorities in a fast-paced environment.
Preferred Qualifications:
Familiarity with Kneat, TrackWise, Veeva, or electronic validation systems.
Experience supporting clean utilities, process equipment, or manufacturing systems.
Understanding of risk assessments, FMEA, and change management processes.
Show more Show less