Validation Engineer

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.