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Senior Validation Engineer
Location: North Chicago, IL
Contract: 12+ month duration with potential for extensions
Work Location: On\-site, 1st shift, five days a week
Automated Systems, Inc. is seeking a Senior Validation Engineer with a minimum of 10 years of experience and a strong understanding of validation principles to support a global pharmaceutical manufacturing client located in North Chicago, IL. In this role, you will support a production site consisting of multiple buildings, including aseptic processing, API pharmaceutical manufacturing, and cosmetics production. This is a hands\-on, high\-impact role for an experienced Validation Engineer who must demonstrate a deep expertise in validation principles and regulated manufacturing environments.
Key Job Responsibilities
Lead and participate in cross\-functional forums including Product Introduction, Validation Planning, Change Control (CRB/CFT), and Validation Review Board (VRB) meetings
Serve as the Validation representative during daily shop floor operations
Provide validation expertise to support investigations, CAPAs, and change activities
Develop, maintain, and manage Validation Master Plans (VMPs), procedures, and internal work trackers
Author, route, review, and approve validation documentation within OneVault, including C&Q documents and DCCs
Review and approve Change Records, assessments, and related actions/extensions in OneTrack
Perform Validation Impact Assessments for document and change controls
Support site\-wide use of Kneat validation software, including template creation, hardware coordination, issue resolution, and user training
Act as the primary point of contact for Kneat system support and continuous improvement
Education and Experience Requirements:
\- Bachelorâs degree in Pharmacy, Engineering, or a related scientific discipline
\- 10+ years of validation experience in regulated manufacturing environments
\- Hands\-on experience supporting aseptic processing, API manufacturing, and pharmaceutical equipment, facility, and utility qualification
\- Strong knowledge of the validation lifecycle, commissioning & qualification (C&Q), change control, and deviation management
\- Experience with electronic quality and validation systems, including document management (e.g., OneVault), change management (e.g., OneTrack), investigations/CAPA (e.g., TrackWise), and validation execution platforms (e.g., Kneat) or equivalent tools
\- Excellent communication and leadership skills with the ability to collaborate effectively across cross\-functional teams
