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.