Senior Validation Engineer

2 weeks ago

Thāne, Maharashtra, India Tek Support Full time

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:

  • 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.

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