Validation Engineer

Overview

Summary:

A minimum of 8 years' work experience in GXP / Analytical lab environment. Experience handling medium to complex GMP instruments such as UV VIS, FTIR, NMR, Polarimeter, XRD, HPLC, GC, etc. Ability to manage a support team onsite/offshore, assign tasks, and provide technical assistance and training. Skilled in managing multiple sites with strong planning and demand management. Experience in reviewing GMP deliverables in a team setting.

Ability to identify process improvement areas and drive efficiency. Strong decision-making skills to handle competing priorities effectively. Experience in internal stakeholder management, collaboration, and periodic metrics reporting.

• Provide lab system administration and support via the ticketing system (e.g., help requests, user access requests).
• Collaborate with lab analysts and end users to confirm problems or requests.
• Resolve issues or fulfill requests (onsite or remotely) by following SOPs and procedural guidelines.
• Coordinate system changes with equipment owners and Quality Assurance representatives.
• Complete change-related documentation.
• Close requests in the ticketing system.

• Track due dates for lab system reviews using a scheduler.
• Coordinate reviews with equipment owners.
• Follow system SOPs for reviews and deliverables.
• Complete tasks required for each review.
• Generate required documents/artifacts and deliverables.
• Finalize documentation with appropriate review and approval.