Engineering - Service - Sr. Validation & Compliance Engineer

TekWissen LLC

Topeka, KS

JOB DETAILS
SALARY
$59.20–$59.20
SKILLS
Analysis Skills, Commissioning, Consumer Software, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Diversity, Drug Manufacturing, FDA (Food and Drug Administration), Internet/Online Service, Manufacturing, Process Improvement, Process Validation, Quality Assurance, Quality Metrics, Risk, Technical Support, Validation Plan, Workforce Management
LOCATION
Topeka, KS
POSTED
1 day ago
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.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/