Validation Engineer

Job Title

JD CQV Engineers are responsible for supporting commissioning, qualification, and validation projects for pharmaceutical facilities, utilities, equipment, and systems. You will play a key role in executing CQV deliverables and ensuring operational readiness from the ground up to support our clients' success.

Responsibilities:

• Assist in commissioning and startup of new equipment, utilities, and cleanroom systems during facility buildout.
• Develop and execute IQ/OQ/PQ protocols for newly installed systems and equipment.
• Prepare and maintain documentation, including validation protocols, plans, reports, and standard operating procedures.
• Support risk assessments and mitigation strategies related to CQV activities.
• Troubleshoot and assist in resolving issues related to equipment and process performance.
• Collaborate with cross-functional teams to align CQV activities with construction and project timelines.
• Coordinate with vendors and contractors to support hand-offs and system turnover.
• Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
• Provide technical support during validation execution and qualification activities.
• Additional responsibilities as required.

Requirements:

• Bachelor's degree in engineering or a related field.
• 7-10 years of commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.
• Proven experience supporting or leading CQV activities during new facility buildouts, including equipment installation and startup.
• Strong background in cleanroom facilities, process equipment, and utility systems.
• Familiarity with project execution and project management tools.
• Deep understanding of regulatory requirements and industry standards (GMP, GAMP, FDA, EMA).
• Knowledge of validation lifecycle and risk-based approaches.
• Excellent analytical and technical problem-solving skills.
• Strong technical writing skills and experience with validation documentation (protocols, reports, procedures, etc.).
• Effective communication and interpersonal skills.