Validation Engineer

Commissioning & Qualification (C&Q) Engineer
We are seeking a mid-level Commissioning & Qualification Engineer to support complex projects in a regulated manufacturing environment. This role will focus on qualification execution, protocol development, system turnover activities, and coordination across engineering, quality, and project teams.
The ideal candidate has experience supporting commissioning and validation efforts for equipment, utilities, or manufacturing systems and can independently manage assigned project scope while ensuring compliance and schedule alignment.

Responsibilities
Execute commissioning and qualification activities for equipment, utilities, and manufacturing systems in regulated environments.
Develop and execute IQ/OQ/PQ protocols, test scripts, and supporting validation documentation.
Own assigned systems through startup, qualification, and turnover to operations.
Coordinate C&Q activities with engineering, quality, vendors, and project teams to support schedule and project milestones.
Support risk assessments, deviations, change controls, and summary reports while ensuring compliance with GMP and regulatory standards.
Participate in system walkdowns, troubleshooting, and issue resolution during commissioning and startup.
Contribute to project planning, status reporting, and support client interactions throughout project execution.
Provide guidance to junior team members and support documentation review as needed.

Qualifications
Bachelor’s degree in Engineering or related technical field.
2–5+ years of experience in commissioning, qualification, validation, or related engineering support.
Experience developing or executing IQ/OQ/PQ protocols in pharmaceutical, biotech, or regulated manufacturing environments.
Working knowledge of GMP, FDA requirements, and industry standards such as ASTM E2500 or ISPE guidelines.
Experience supporting equipment, process, or utility qualification preferred.
Familiarity with deviations, risk assessments, and validation documentation practices.
Exposure to tools such as Kneat, Smartsheet, or similar project/validation platforms is a plus.
Strong communication, technical writing, and project coordination skills.
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