Engineering Service Sr. Validation & Compliance Engineer
Topeka, KS - USA
Job Summary
Overview
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is to one of Our clients who is a global leader in analytical testing deliver a comprehensive portfolio of complete solutions - systems software consumables and on-site and online services - with one overarching purpose: to help make the world healthier cleaner and more sustainable.
Job Title: Engineering - Service - Sr. Validation & Compliance Engineer
Duration: 6 Months
Location: Topeka Kansas 66603
Job Type: Temporary Assignment
Work Type: Remote
Work Locations: Indianapolis IN Kansas City KS St. Louis MO Columbus OH
Description:
- Develop execute and document commissioning qualification and validation protocols (IQ/OQ/PQ) for new and modified equipment utilities and facilities.
- Author and review qualification documents test scripts deviation reports and summary reports.
- Perform risk-based commissioning and qualification activities in accordance with FDA EMA and internal quality standards.
- Coordinate closely with engineering quality assurance validation and operations teams throughout the C&Q lifecycle.
- Support technology transfer process validation and handover to manufacturing.
- Participate in deviation investigations CAPA implementation and continuous improvement of CQV processes.
Depth of Experience:
- Mid to Senior level (typically 3 10 years in CQV within Job pharmaceutical manufacturing) Commissioning & Qualification (C&Q)
TekWissen Group is an equal opportunity employer supporting workforce diversity.