Senior Validaiton Engineer

About the role

We are seeking a CQV Engineer with 7–11 years of experience supporting commissioning, qualification, and validation activities for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes. This role is responsible for the execution of commissioning and qualification activities, including system walkdowns, protocol execution, documentation review, discrepancy management, and system turnover support. The CQV Engineer will work cross-functionally with Engineering, Construction, Automation, Operations, Quality, and project teams to ensure systems are installed, tested, documented, and released in accordance with approved requirements, project timelines, and regulatory expectations.

Physical demands: While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as navigate production, utility, construction, and manufacturing areas. The employee may occasionally be required to stand for extended periods, climb stairs, stoop, kneel, or lift and carry objects weighing up to 25 pounds. Specific vision abilities required include close vision and the ability to adjust focus.

Work environment: Duties will be performed in a combination of office, laboratory, manufacturing, utility, and construction environments. The employee may be exposed to varying noise levels and active project areas while supporting field execution, system walkdowns, and qualification activities. Appropriate personal protective equipment (PPE) may be required when working in designated operational or construction environments.

Responsibilities

• Review approved design, vendor, turnover, and qualification documentation in preparation for commissioning and qualification execution activities.
• Support system walkdowns, field verification activities, construction completion reviews, and readiness assessments.
• Execute commissioning and qualification protocols, including IQ, OQ, PQ, functional testing, and other approved test documentation as applicable.
• Verify installation of equipment, utilities, instrumentation, controls, and automation systems against approved drawings, specifications, vendor documentation, and design requirements.
• Verify system functionality, alarms, interlocks, controls, instrumentation, and operational requirements during execution activities.
• Coordinate testing activities with Engineering, Construction, Automation, Operations, Quality Assurance, and equipment vendors to support execution schedules.
• Perform and document field testing activities and collect objective evidence required to support protocol execution and qualification deliverables.
• Identify, document, and track discrepancies