Validation Engineer

Siegfried•Grafton, WI

About The Position

Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact. Your Role: The Validation Engineer manages the technical aspects of assigned products and new manufacturing processes. This role supports manufacturing operations through preparation of batch and cleaning records, investigation and resolution of process issues, implementation of corrective actions, and continuous improvement of yields, costs, and cycle times.

Requirements

Bachelor's degree in chemical engineering is preferred.
0–5 years of hands-on experience in a pharmaceutical or fine chemical batch manufacturing environment preferred.
Working knowledge of cGMP regulations is strongly preferred.

Nice To Haves

Familiarity with Visalia and Blue Mountain maintenance systems, SAP is a plus.

Responsibilities

Collaborates closely with Chemical Development, Production, Quality, and other cross-functional teams.
Manages the transfer of assigned products and/or new processes into manufacturing.
Prepares, reviews, and supports execution of Batch Log Records and Cleaning Log Records.
Trains production personnel on Batch Log Records, Cleaning Log Records, and validation protocols.
Provides technical support to manufacturing operations for assigned products.
Monitors manufacturing performance, costs, yields, and cycle times; identifies and implements cost-reduction and efficiency-improvement initiatives.
Reviews production campaigns and prepares campaign summary reports.
Acts as the manufacturing representative on capital projects related to assigned products.
Conducts product and process failure investigations and implements corrective and preventive actions as needed.
Supports equipment specification, qualification, and validation activities, including IQ/OQ.
Participates in deviation investigations, change requests (CRs), and master batch record (MBR) development and updates.
Ensures compliance with all applicable cGMP, SHE, DEA, and regulatory requirements.
Adheres to the Siegfried Code of Conduct and maintains the highest standards of ethical and professional behavior.