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Weil Group, Inc

Validation Engineer

Weil Group, Inc, Yauco, Yauco, us, 00698

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Education & Certifications 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.

Technical Skills

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).

Experience

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.

Soft Skills

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).

Other Requirements

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

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