Validation Engineer

United Consulting Hub, Inc.

United States

On-site

USD 52,000 - 76,000

Full time

9 hours ago
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Job summary

United Consulting Hub, Inc. seeks an entry-level Validation Engineer to support validation and qualification activities for pharmaceutical equipment, manufacturing processes, utilities, and facilities.

The role involves assisting with protocols, testing, documentation, and compliance to maintain validated state of regulated systems. You will work with Quality Assurance, Engineering, Production, and Maintenance teams to execute validation assignments, maintain records, and participate in periodic

Qualifications

  • Basic understanding of validation principles and documentation.
  • Familiarity with GMP, GDP, IQ/OQ/PQ requirements.
  • Strong analytical and technical writing skills.
  • Knowledge of risk assessment and deviation handling.

Responsibilities

  • Assist validation activities for pharmaceutical equipment, processes, and utilities.
  • Prepare, review, and execute validation protocols and test scripts.
  • Support IQ, OQ, and PQ activities and document results.
  • Coordinate with QA, Eng, Production, and Maintenance teams.
  • Maintain validation records and support audits.

Skills

GMP knowledge
Documentation
Validation principles
Analytical thinking
Technical writing
Risk assessment

Education

Bachelor's degree

Job description

We are seeking an entry-level Validation Engineer to support validation and qualification activities for pharmaceutical equipment, manufacturing processes, utilities, and facilities. The candidate will assist with validation protocols, testing, documentation, and compliance activities to maintain the validated state of regulated systems.

Key Responsibilities:

  • Assist with equipment, process, cleaning, facility, and utility validation activities in pharmaceutical and biotechnology environments.
  • Prepare, review, and execute validation protocols, test scripts, and reports under the guidance of senior validation engineers.
  • Support IQ, OQ, and PQ activities for manufacturing equipment, laboratory instruments, and critical utility systems.
  • Participate in process validation and cleaning validation activities by collecting data and documenting test results.
  • Review technical documents, equipment specifications, SOPs, and validation records for completeness and accuracy.
  • Assist with deviation investigations, change control assessments, and corrective and preventive action documentation.
  • Coordinate with Quality Assurance, Engineering, Production, and Maintenance teams to complete validation assignments.
  • Maintain validation records and support periodic reviews, requalification activities, and regulatory audit preparation.

Skills Required:

  • Basic understanding of pharmaceutical validation principles, equipment qualification, and process validation.
  • Knowledge of GMP, GDP, IQ, OQ, PQ, validation protocols, and documentation requirements.
  • Familiarity with equipment specifications, calibration records, process parameters, and technical drawings.
  • Understanding of risk assessments, deviation management, change control, and root cause analysis.
  • Strong analytical, technical writing, communication, and organizational skills.

Preferred:

  • Bachelor's degree in Mechanical Engineering, Chemical Engineering, Pharmacy, Biotechnology, or a related field.
  • Academic or internship experience involving validation, quality systems, or pharmaceutical manufacturing.
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