Validation Engineer

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Biomedical, or related field).
• Advanced degree or professional certifications (e.g., Six Sigma, ASQ, CQE) is a plus.

• Knowledge of validation methodologies (IQ, OQ, PQ) and protocols.
• Familiarity with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and FDA/ISO regulatory requirements.
• Experience with risk assessment tools (FMEA, HACCP, risk matrix).
• Proficiency in calibration and verification of instruments and equipment.
• Ability to develop, execute, and document validation protocols and reports.
• Proficient in using data analysis tools (Excel, Minitab, or equivalent).

• 2–5 years of experience in validation within the pharmaceutical, medical device, biotechnology, or manufacturing industry.
• Hands-on experience with process, equipment, cleaning, and software validation.
• Experience in troubleshooting and root cause analysis.

• Strong analytical and problem-solving skills.
• Excellent technical writing and documentation skills.
• Ability to work independently and in a team-oriented environment.
• Strong organizational and time management abilities.
• Effective communication skills in English (written and verbal).

• Willingness to work in cleanroom or controlled environments.
• Availability to work flexible hours, including weekends, if required.
• Knowledge of safety procedures and compliance with EHS regulations.

Weil Group