Lead Qualification & Validation Engineer – On-Site PR

Cis-International-LLC; Vega Baja (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Cis-International-LLC in Vega Baja, Puerto Rico, seeks a highly skilled Commissioning and Qualification (C&Q) professional on a full-time, on-site basis to support a pharmaceutical manufacturing operation. The role leads qualification activities for facilities, utilities, equipment and computerized systems, develops validation strategies, and ensures compliance with global regulatory standards.

Responsibilities include planning, executing, documenting IQ/OQ/PQ protocols, monitoring progress,

Qualifications

• Bachelor's degree in a related scientific discipline.
• 3–5 years of pharmaceutical/manufacturing experience.

Responsibilities

• Lead end-to-end qualification and lifecycle management of facilities, utilities, equipment, and systems.
• Develop validation strategies, acceptance criteria, and sampling plans.
• Prepare and approve validation documentation (IQ/OQ/PQ, VMPs, URS, design specs, risk assessments).
• Direct protocol execution, data collection, analysis, and CAPA investigations.
• Monitor project status, risks, and deliverables; communicate with leadership.
• Ensure regulatory compliance with 21 CFR, EU GMP Annexes, ICH guidelines.

Skills

Validation leadership

Project management

Regulatory compliance

Risk assessment

Data analysis

Education

Bachelor's degree in Engineering/Science

Job description

Cis-International-LLC in Vega Baja, Puerto Rico, seeks a highly skilled Commissioning and Qualification (C&Q) professional on a full-time, on-site basis to support a pharmaceutical manufacturing operation. The role leads qualification activities for facilities, utilities, equipment and computerized systems, develops validation strategies, and ensures compliance with global regulatory standards.

Responsibilities include planning, executing, documenting IQ/OQ/PQ protocols, monitoring progress,