Validation Engineer

Job Title

Key Responsibilities:

• Develop and execute CQV documentation including protocols (IQ/OQ/PQ), reports, risk assessments, and traceability matrices.
• Support or lead commissioning and qualification activities for equipment, systems, and utilities (e.g., HVAC, WFI, clean steam, autoclaves, filling lines).
• Coordinate with cross-functional teams including engineering, quality, production, and automation to ensure successful project execution.
• Perform data integrity reviews and ensure documentation complies with GDP (Good Documentation Practices).
• Ensure alignment with internal procedures and regulatory requirements (e.g., FDA 21 CFR Part 11, Annex 15, ASTM E2500).
• Participate in FAT/SAT testing and support deviation investigation, change control, and CAPA processes.
• Collaborate with project stakeholders to support facility startups and technology transfers.
• Maintain validation master plans (VMPs), schedules, and project status reports.

Qualifications:

• Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, or related field) or Life Sciences.
• 3+ years of experience in CQV roles in the pharmaceutical, biotechnology, or medical device industry.
• Strong knowledge of GMP regulations, validation life cycle, and quality systems.
• Experience with automated systems, data integrity principles, and GAMP 5 guidance.
• Proficiency in validation and risk assessment methodologies (FMEA, URS, DQ, etc.).
• Excellent organizational, technical writing, and communication skills.

Preferred

Skills:

• Experience with aseptic manufacturing and cleanroom environments.
• Familiarity with project management tools and systems (MS Project, Primavera, etc.).
• Lean Six Sigma or similar process improvement training.
• Ability to work in a fast-paced, dynamic project environment.