Validation Engineer

GxP Associates; California; In loco; USD 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

GxP Associates seeks a motivated Validation Engineer to support validation activities for equipment, systems, processes, and facilities in a regulated environment. This early-career role offers growth in GMP compliance, qualification documentation, and regulated manufacturing operations.

You will assist with IQ/OQ/PQ, develop and execute validation protocols, and collaborate with Quality, Engineering, Manufacturing, IT, and Operations to ensure compliance and readiness for inspections.

Competenze

• Bachelor's degree required in engineering, life sciences, pharma, or related field.
• 0-3 years in validation, qualification, manufacturing, or regulated industry.
• Basic GMP understanding.
• Familiarity with IQ/OQ/PQ preferred.
• Strong writing and documentation skills.
• Analytical and problem-solving abilities.
• Ability to work cross-functionally.

Mansioni

• Support validation activities for equipment, processes, facilities, and systems.
• Assist development and execution of validation protocols and reports.
• Support IQ, OQ, PQ and other qualification activities.
• Review and maintain validation docs per procedures.
• Support risk assessments, traceability, and deviations related to validation.
• Assist with change controls and corrective actions.
• Participate in equipment commissioning, testing, and qualification.
• Ensure GMP compliance in validation activities.

Conoscenze

GMP knowledge

IQ/OQ/PQ concepts

Technical writing

Analytical skills

Cross-functional collaboration

Documentation skills

Formazione

Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related field

Descrizione del lavoro

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