Validation Engineer

Job Summary

We are seeking a motivated Validation Engineer to support validation activities for equipment, systems, processes, and facilities in a regulated environment. This is an excellent opportunity for an early-career engineer to develop experience in GMP compliance, qualification, validation documentation, and regulated manufacturing operations.

Key Responsibilities

• Support equipment, process, facility, and system validation activities.
• Assist with development and execution of validation protocols and reports.
• Support IQ, OQ, PQ, and other qualification activities.
• Review and maintain validation documentation in accordance with company procedures.
• Assist with requirements gathering, risk assessments, and traceability documentation.
• Support deviation investigations, change controls, and corrective actions related to validation activities.
• Participate in equipment commissioning, testing, and qualification activities.
• Ensure validation activities are performed in accordance with applicable GMP requirements.
• Collaborate with Quality, Engineering, Manufacturing, IT, and Operations teams.
• Support preparation for internal and external regulatory inspections.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related field.
• 0–3 years of experience in validation, qualification, manufacturing, or a regulated industry.
• Basic understanding of GMP and regulated manufacturing environments.
• Familiarity with IQ/OQ/PQ concepts is preferred.
• Strong technical writing and documentation skills.
• Good analytical and problem-solving abilities.
• Ability to work effectively in a cross-functional environment.

Preferred Skills

Validation | Qualification | IQ/OQ/PQ | GMP | GAMP 5 | 21 CFR Part 11 | Risk Assessment | Change Control | Deviations | Commissioning