Validation Engineer

Overview

kdc/one Northern Labs, 5800 West Dr, Manitowoc, Wisconsin, United States of America

Posted Thursday, April 10, 2025 at 5:00 AM

KDC is a network of best-in-class custom formulators and manufacturers of color cosmetics, skincare, haircare, bath & body, fragrance, deodorant, home, health, industrial, and auto care products. KDC delivers high-touch innovation, operational excellence, and speed to market to well-known and emerging beauty, personal, and specialty companies from coast to coast. KDC has its head office in Longueuil, Québec. In addition, KDC has 10 operating facilities located throughout North America.

Altogether, the company employs nearly 4,800 talented and dedicated employees in North America.

The purpose of the Validation Engineer is to identify, design, execute, and maintain the validation lifecycle of all applicable manufacturing processes associated with the production of a drug item, to ensure said processes are capable of consistently delivering quality products. In addition, the Validation Engineer is to help ensure all products produced by Northern Labs are in line with and meet customer expectations and regulatory requirements (FDA cGMP, BRCGS Consumer Products standard, & ISO
9001 standard).

• New Product Introduction:
  Identify potential processes that will require validation prior to new product inception/implementation.
• Identify potential failure modes during manufacturing by preparing comprehensive Failure Mode Effects Analyses (FMEAs).
• Write Protocols for Installation Qualification, Operational Qualification, and Performance Qualification. Work with contract customers (where applicable) and/or internal departments as a cross functional team to create peer reviewed protocols prior to execution.
• Support (where necessary) the execution of IQ, OQ, and PQ Protocols with various internal departments.
• Compile required data and supporting documentation from execution of the Protocol; analyze applicable data and write the final Report, to provide objective evidence that the process is capable of consistent output, and therefore approved for “routine production”.
• Create/implement effective control plans.
• Create/implement Master Validation Plans (MVPs).
• Responsible for generating controlled documents to ensure the manufacturing processes are being followed within established validation parameters, and subsequently producing product that meets customer and regulatory requirements.
• Process various Quality Management System (QMS) documents as they pertain to validated processes/products, including Non-Conformance (NC) Reports, Corrective and Preventive Actions (CPAs), Deviations, Waivers.
• Use Root Cause Analysis to identify the true root cause of NC product or processes. Based on the root cause, work as a team with various departments to create an action plan to prevent reoccurrence.
• Work with contract customers for approvals of NCs, CPAs, Deviations/Waivers when necessary.
• Existing Products:
  Conduct assigned sections of Annual Product Reviews (APRs) of regulated/drug products.
• Conduct Document Reviews to ensure the document accurately reflects the actual process, the processes are actually being followed, and the process is within the established validation parameters.
• Recommend and document changes to validated processes through Management of Change (MOC), responsible for the Origination and Rationale of the proposed change prior to submission for approval. Once approved, update controlled documents for manufacturing.
• Effectively manage the continuous validation lifecycle of a product/process by conducting reviews for re-validation and updating the associated Master Validation Plan (MVP).
• Provide support for external audits; process audit findings as requested by management.
• Act as a liaison and knowledge reference between Quality and various departments (i.e., Blending, Filling), to ensure procedures are followed within the validated parameters, to ensure product is produced right first time.

• Work with customers to resolve discrepancies in specifications, processes, etc. to ensure both…