Validation Engineer

Brentwood Industries, Inc.•Reading, PA

11h•Onsite

About The Position

The Validation Engineer will lead validation activities across our production lines. They will have a strong background in quality systems, process validation, and regulatory compliance, with specific experience in plastics manufacturing. This role is critical to ensuring product integrity, customer satisfaction, and continuous improvement. Employee may perform other related duties as required to meet the ongoing needs of the organization.

Requirements

Bachelor’s degree in; Mechanical, Electro-Mechanical, Manufacturing or Industrial Engineering preferred.
Minimum 2 years of experience in quality/validation engineering within a manufacturing environment; plastics manufacturing preferred.
Strong knowledge of quality standards (ISO 9001).
Hands-on experience with validation protocols (IQ/OQ/PQ).
Excellent communication, organizational, and problem-solving skills.
Proficient in Microsoft Office and QMS software.
Knowledge of regulatory standards in medical device or automotive sectors.

Responsibilities

Develop and implement validation protocols for plastic manufacturing processes primarily focused on NPD.
Conduct equipment, process, and product validations (IQ/OQ/PQ), ensuring compliance with internal standards and external regulations (ISO 9001).
Responsible for the following validation documentation: W.I.’s, PFMEA’s, packaging instructions, setup instructions for new parts.
Be the liaison between process engineering and design engineering to assist with tooling modifications and recommendations.
Clearly communicate and execute modifications for process engineering to develop new product development.
Communicate required tooling design changes to the design department for final revision.
Assist engineering and production teams to improve process capability and product consistency.
Conduct internal and external audits, including supplier quality assessments.
Support customer quality requirements, including documentation, reporting, and communication.
Manage projects across multiple departments for new and existing tooling needs and modifications.