Validation Engineer

Flexible & Integrated Technical Services, LLC • Añasco, PR

2d

About The Position

For Validation services in the Quality/Validation area.

Requirements

• Bachelor’s degree in Engineering
• At least two (2) years of previous experience in Validation activities within the Pharmaceutical & Medical Devices Industry.
• Bilingual: Spanish and English
• Excellent communication skills
• Positive attitude
• Validation Life Cycle (IQ, OQ, PQ)
• Manufacturing processes, equipment, cleaning, and computerized systems validation
• Regulatory requirements and standards (FDA, ISO, cGMP)
• Statistical analysis tools (e.g., Minitab, Excel)
• Change Control and validation impact assessments

Nice To Haves

• Treats everyone they meet like family, especially our resources, clients, and team members.
• Customer service pro.
• Full of bright ideas and eager to innovate.
• Always bringing top-quality results to the table.

Responsibilities

• Develop, execute, and document validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support validation activities for manufacturing processes, equipment, cleaning procedures, and computerized systems.
• Participate in equipment qualification, requalification, and validation lifecycle activities to ensure compliance and operational readiness.
• Perform validation impact assessments associated with Change Controls (CN/CR) and support implementation activities.
• Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, R&D, and Regulatory Affairs to support validation projects.
• Analyze validation data using statistical tools and methodologies to support conclusions and recommendations.
• Support protocol deviations, investigations, corrective actions, and continuous improvement initiatives.
• Maintain accurate validation documentation in compliance with Good Documentation Practices (GDP) and applicable regulations.
• Support internal audits and regulatory inspections by providing validation documentation and technical expertise.
• Track validation project timelines, deliverables, and status updates to ensure successful execution.

What This Job Offers

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