Validation Engineer II - capital projects

CIS International • Vega Baja, PR

2d • Onsite

About The Position

Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico. This role involves supporting the execution of commissioning, qualification, and validation activities for manufacturing equipment, facilities, utilities, and computerized systems. The position also requires assisting with the development, review, and execution of qualification and validation documentation, participating in protocol execution, analyzing test data, and maintaining validation documentation to ensure compliance.

Requirements

• Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 0-3 years’ experience in pharmaceutical or regulated manufacturing environment.
• Previous Oral Solid Dose (OSD) manufacturing experience is ideal.
• Spanish and English language proficiency.
• Willingness to support non-admin hours.

Responsibilities

• Support the execution of commissioning, qualification, and validation activities for manufacturing equipment, facilities, utilities, and computerized systems.
• Assist with the development, review, and execution of qualification and validation documentation, including Validation plans, Risk assessments, Commissioning documents, IQ, OQ, and PQ protocols, Test scripts, Final reports
• Participate in protocol execution activities, including: Data collection and documentation, Equipment testing and verification, Utility and environmental monitoring support, Sample collection, Recording and compilation of results
• Analyze test data, identify discrepancies, and assist in troubleshooting qualification and validation issues under the direction of senior personnel.
• Maintain validation documentation and ensure records are complete, accurate, and compliant with data integrity requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level