United Consulting HubRemote
Validation Engineer
United States of America
Contract
2 hours ago
H1B Sponsor Likely
Key skills
Validation lifecycleGMP environmentProcess validationCleaning validationCSV validationIQ protocolOQ protocolPQ protocolSOP preparationValidation protocol preparationALCOA+ principles21 CFR Part 11GAMP 5
About this role
United Consulting Hub is seeking a Junior Validation Engineer to support validation activities for pharmaceutical and biotech processes. The role involves assisting in validation tasks, ensuring compliance with regulatory standards, and preparing necessary documentation.
Responsibilities:
- Assist in process, cleaning, and CSV validation; support planning, execution, and reporting
- Execute IQ, OQ, PQ protocols; record results and handle deviations
- Prepare/review SOPs, validation protocols, and reports; follow ALCOA+ principles
- Ensure compliance with GMP, 21 CFR Part 11, and GAMP 5; support audits and inspections
Requirements:
- 0-2 years of experience
- Supports validation activities for pharmaceutical and biotech processes, equipment, and systems to ensure compliance with regulatory standards such as FDA and WHO
- Assist in process, cleaning, and CSV validation; support planning, execution, and reporting
- Execute IQ, OQ, PQ protocols; record results and handle deviations
- Prepare/review SOPs, validation protocols, and reports; follow ALCOA+ principles
- Ensure compliance with GMP, 21 CFR Part 11, and GAMP 5; support audits and inspections
- Basic understanding of validation lifecycle
- Knowledge of GMP environment
- Good documentation and technical writing skills
- Attention to detail and problem-solving ability