Qualification & Validation Engineer II - capital projects

CIS International•Vega Baja, PR

1d•Onsite

About The Position

This role provides Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department within the pharmaceutical manufacturing industry in Puerto Rico. The position involves technical leadership for commissioning, qualification, and computer system validation activities, ensuring compliance with regulatory standards.

Requirements

Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
3-5 years’ experience in pharmaceutical or regulated manufacturing environment.
Previous Oral Solid Dose (OSD) manufacturing experience is ideal.
Proficiency in Spanish and English.
Willingness to support non-admin hours.

Responsibilities

Lead and execute end-to-end qualification and lifecycle management of facilities, utilities, manufacturing equipment, process systems, and computerized systems.
Plan, coordinate, and deliver qualification and validation project milestones within scope, timeline, and budget constraints.
Develop, review, approve, and execute validation lifecycle documentation, including Validation Master Plans, User Requirements Specifications (URS), Functional and Design Specifications, Risk Assessments, Commissioning Plans, IQ/OQ/PQ protocols, and summary reports.
Direct protocol execution activities, including data collection, field sampling, data trending, statistical analysis, deviation assessment, root cause investigations, and implementation of corrective actions.
Monitor, track, and communicate validation project status, risks, and deliverables to project teams and leadership.
Develop and scientifically justify validation strategies, acceptance criteria, sampling plans, and protocol designs based on risk management principles, process understanding, and industry best practices.
Evaluate and document the impact of change controls on qualified systems, validated processes, facilities, utilities, and computerized systems, ensuring compliance with site and regulatory requirements.
Lead and support investigations, deviations, and CAPAs, providing technical expertise to resolve complex quality, validation, and manufacturing issues.
Develop, implement, and continuously improve validation procedures, standards, policies, and lifecycle management practices aligned with regulatory expectations and industry trends.
Maintain compliance with current global regulatory requirements and industry guidance, including but not limited to: 21 CFR Parts 210, 211, and 11; EU GMP Annex 11 and Annex 15; ICH Q8, Q9, and Q10; ISPE Baseline Guides and GAMP 5; and applicable domestic and international regulatory standards.
Manage multiple high-priority projects simultaneously, balancing competing demands while consistently meeting aggressive timelines and business objectives.
Perform other duties and special projects as assigned.