Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Job Description:

We are seeking a highly motivated and detail-oriented Validation Engineer to join our quality and compliance team. The successful candidate will be responsible for planning, executing, and documenting validation activities for equipment, processes, cleaning, software, and systems in accordance with internal procedures and industry regulations. This role plays a key part in ensuring that products are manufactured consistently and in compliance with FDA, ISO, and other regulatory standards.

Requirements/Qualifications:

Experience:

2–5 years of hands-on experience in validation within the pharmaceutical, medical device, biotechnology, or manufacturing industry. Demonstrated experience with process, equipment, cleaning, and software validation. Experience with deviation management, root cause analysis, and CAPA.

Technical Skills:

Proficient in validation methodologies (IQ, OQ, PQ). Strong understanding of GMP, GDP, and applicable FDA/ISO regulatory standards. Familiarity with risk assessment tools (FMEA, HACCP). Competent in equipment calibration and verification techniques. Proficient in Microsoft Office Suite and statistical analysis tools (e.g., Excel, Minitab).

Soft Skills:

Strong analytical thinking and problem-solving abilities. Excellent technical writing and documentation skills. Ability to manage multiple tasks and prioritize workload effectively. Capable of working both independently and as part of a team. Clear and professional communication skills in English (written and verbal).

Education & Certifications:

Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, Biomedical, or related discipline) is required. Advanced degree or professional certifications (e.g., Six Sigma, ASQ, CQE) are a plus.