Validation Engineer

ProQuality Network; Vega Baja (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

ProQuality Network is seeking a Validation Engineer to lead commissioning, qualification, and validation activities across facilities and equipment in North of Puerto Rico. The role involves planning, coordinating, and delivering validation milestones within scope, timeline, and budget while maintaining compliance with CFR, ICH, ISPE, and GAMP5 guidelines.

The candidate will develop and execute validation lifecycle documents, lead protocol execution, data collection and analysis, and support

Qualifications

• Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or related field.
• 7–10 years’ experience for Senior role; 3–5 years for Engineer II; 0–3 years for Engineer I.
• Experience in pharmaceutical or regulated manufacturing environment; OSD experience preferred.

Responsibilities

• Lead commissioning, qualification and validation activities for facilities, utilities, equipment, process systems and computerized systems.
• Develop, review and execute validation documentation (VMPs, URS, FDS, risk assessments, IQ/OQ/PQ, protocols, reports).
• Direct protocol execution: data collection, sampling, data analysis, deviations, CAPAs.
• Monitor project status and communicate risks/deliverables to teams/leaders.
• Maintain compliance with CFR, ICH, ISPE, GAMP5 and data integrity requirements.

Skills

Technical leadership

Project planning

Validation lifecycle

Data analysis

CAPA investigations

Regulatory compliance

Education

Bachelor's degree in Engineering

Job description

Title: Validation Engineer

Location: North of Puerto Rico (Only for Puerto Rico Residents)

Key Competencies

Validation Engineer II and III:

• Provide technical leadership for commissioning, qualification, and computer system validation activities, including: facilities, utilities, manufacturing equipment, process systems, and computerized systems.
• Planning, coordinating, and delivering qualification and validation project milestones within scope, timeline, and budget constraints.
• Developing, reviewing, approving, and executing 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.
• Directing protocol execution activities, including data collection, field sampling, data trending, statistical analysis, deviation assessment, root cause investigations, and implementation of corrective actions.
• Monitoring, tracking, and communicating validation project status, risks, and deliverables to project teams and leadership.
• Lead and support investigations, deviations, and CAPAs, providing technical expertise to resolve complex quality, validation, and manufacturing issues.
• Maintain compliance with current global regulatory requirements and industry guidance (CFR, ICH, ISPE, GAMP5, etc.)
• 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.

Validation Engineer I

• 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.
• Basic understanding of cGMP regulations and pharmaceutical manufacturing principles.

Experience / Qualifications

• Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Senior Qualification & Validation Engineer: Candidate should have 7-10 years’ experience in pharmaceutical or regulated manufacturing environment; ideally, the candidate will have previous Oral Solid Dose (OSD) manufacturing experience.
• Qualification & Validation Engineer II: Candidate should have 3-5 years’ experience in pharmaceutical or regulated manufacturing environment; ideally, the candidate will have previous Oral Solid Dose (OSD) manufacturing experience.
• Validation Engineer I: Candidate should have 0-3 years’ experience in pharmaceutical or regulated manufacturing environment; ideally, the candidate will have previous Oral Solid Dose (OSD) manufacturing experience.