
Senior Validation Engineer
3 weeks ago
Job Title: Validation Training Engineer QC & Automation Systems
Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Industry: Pharmaceuticals / Biologics / Medical Devices
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:
- Bachelors or Masters 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.
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