Senior Validation Engineer

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Job Overview:

We are seeking a Validation Training Engineer to design, deliver, and maintain training programs for Quality Control (QC) laboratory systems, computer system validation (CSV), and automation compliance in a pharmaceutical manufacturing environment. The role ensures employees are equipped with the knowledge and skills to operate validated systems in compliance with GxP, FDA, and EMA requirements.

Key Responsibilities:

• Develop and deliver training programs on validation procedures for QC laboratory instruments, automated systems, and computerized equipment.
• Train QC and engineering staff on preparation and execution of validation deliverables, including URS, DQ, IQ, OQ, PQ, and risk assessments.
• Conduct hands-on workshops for LIMS, chromatography data systems, and integrated laboratory instrumentation operation and compliance.
• Provide training on GxP requirements, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles as applied to QC systems.
• Design refresher courses and periodic retraining for staff to maintain validated state awareness and readiness for audits.
• Train cross-functional teams on deviation documentation, CAPA processes, and change control procedures related to QC systems.
• Deliver onboarding training for new hires on QC automation systems and validation compliance expectations.
• Create training materials, SOP-based job aids, and validation process documentation for easy reference.
• Support mock audit sessions and train staff on responding to regulatory inspections.

Qualifications:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or related discipline.
• 8+ years of validation or QC experience in pharmaceutical or biologics manufacturing.
• Strong understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and ICH guidelines.
• Experience designing and delivering technical and compliance training in a regulated environment.
• Knowledge of QC laboratory systems, CSV, and automation tools.
• Excellent communication, presentation, and documentation skills.