Validation Engineer

Commissioning Partners; Kentucky; On-site; USD 60,000 - 90,000; Full time

Job summary

Commissioning Partners seeks a motivated Validation Engineer to support validation and qualification activities in a GMP-regulated pharmaceutical environment. You will develop and execute validation documents for equipment, facilities, utilities, and computerized systems.

Responsibilities include preparing URS, FDS, IQ/OQ/PQ protocols, writing test scripts, executing qualification testing, and ensuring ALCOA+ data integrity. Collaboration with Engineering, Manufacturing, QA, and IT is essential.

Qualifications

• Strong technical writing and documentation skills.
• Good communication and interpersonal skills.
• Ability to work effectively in a cross-functional team environment.
• Basic understanding of GMP and FDA regulations.
• Familiarity with validation lifecycle concepts and GMP documentation.
• Understanding of IQ/OQ/PQ, FAT/SAT, and validation protocols is preferred.

Responsibilities

• Support qualification and validation activities for GMP manufacturing equipment, facilities, utilities, and systems.
• Assist in preparing and reviewing validation documentation, including URS, FDS, Validation Plans, IQ/OQ/PQ protocols, Test Scripts, and Traceability matrices.
• Execute and document IQ/OQ/PQ and qualification testing under approved protocols.
• Assist with equipment and utility qualification including HVAC, WFI, clean steam, and other utilities.
• Support GMP documentation and data integrity requirements in accordance with ALCOA+ principles.
• Assist with deviation, discrepancy, CAPA, and change-control investigations related to validation activities.
• Review test results and supporting documentation to ensure compliance with procedures and protocols.
• Work with Engineering, Manufacturing, QA, IT, and cross-functional teams during validation projects.
• Support FAT/SAT activities and vendor documentation reviews when required.
• Maintain accurate validation records and ensure documentation is completed according to GMP requirements.
• Participate in internal and external audit preparation and provide validation documentation as requested.
• Ensure validation activities comply with FDA, cGMP, GAMP 5 and company procedures.

Skills

Technical writing

Documentation

Cross-functional teamwork

Communication

GMP awareness

Education

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, Computer Science

Job description

We are seeking a motivatedValidation Engineer to support validation and qualification activities within a GMP-regulated pharmaceutical environment. The candidate will assist with the development and execution of validation documentation, protocols, testing, and compliance activities for equipment, facilities, utilities, and computerized systems.

Key Responsibilities

• Support qualification and validation activities for GMP manufacturing equipment, facilities, utilities, and systems.
• Assist in preparing and reviewing validation documentation, including:
• User Requirements Specifications (URS)
• Functional/Design Specifications
• Validation Plans
• IQ/OQ/PQ protocols
• Test Scripts
• Traceability/Requirements Matrices
• Validation Summary Reports
• Execute and document IQ/OQ/PQ and qualification testing under approved protocols.
• Assist with equipment and utility qualification, including manufacturing equipment, HVAC, purified water, WFI, clean steam, compressed air, and other critical utilities.
• Support GMP documentation and data integrity requirements in accordance with ALCOA+ principles.
• Assist with deviation, discrepancy, CAPA, and change-control investigations related to validation activities.
• Review test results and supporting documentation to ensure compliance with approved procedures and protocols.
• Work with Engineering, Manufacturing, Quality Assurance, IT, and other cross-functional teams during validation projects.
• Support FAT/SAT activities and vendor documentation reviews when required.
• Maintain accurate validation records and ensure documentation is completed according to GMP requirements.
• Participate in internal and external audit preparation and provide validation documentation as requested.
• Ensure validation activities comply with applicable FDA, cGMP, GAMP 5, and company procedures.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, Computer Science, or a related field.
• 0–3 years of experience in validation, qualification, commissioning, engineering, or a GMP-regulated environment.
• Basic understanding of GMP and FDA regulations.
• Familiarity with validation lifecycle concepts and GMP documentation.
• Understanding of IQ/OQ/PQ, FAT/SAT, and validation protocols is preferred.
• Strong technical writing and documentation skills.
• Good communication and interpersonal skills.
• Ability to work effectively in a cross-functional team environment.

Preferred Qualifications

• Exposure to CSV/CSA concepts and computerized systems.
• Familiarity with 21 CFR Part 11 and electronic records/electronic signatures.
• Knowledge of GAMP 5 and risk-based validation approaches.
• Experience with deviations, CAPAs, change controls, and investigations.
• Exposure to URS, FRS, risk assessments, RTMs, and validation summary reports.
• Experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments.