QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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We are seeking an experienced Validation / Commissioning Specialist to support a special project involving the replacement and qualification of load cells in a pharmaceutical manufacturing environment.

Project Overview

The selected candidate will support commissioning, qualification, validation, and documentation activities associated with the installation and startup of the new system.

Position Responsibilities

• Execute commissioning and qualification activities for equipment upgrades and system replacements.
• Support installation, operational, and performance qualification protocols (IQ/OQ/PQ).
• Ensure compliance with current cGMP regulations and pharmaceutical industry standards.
• Develop and review validation, commissioning, and technical documentation.
• Coordinate validation activities within a regulated manufacturing environment.
• Support computer system validation (CSV) activities associated with equipment integration.
• Utilize digital validation management systems, including ALM platforms.
• Collaborate with engineering, manufacturing, quality, and validation teams.

Minimum Requirements

• Bachelor’s degree in Engineering, Sciences, or related technical field preferred.
• Background in pharmaceutical manufacturing environments.
• Experience in commissioning and qualification activities.
• Strong knowledge of cGMP regulations and compliance requirements.
• Minimum of 5 years of experience in equipment and computer system validation.
• Experience working with digital validation systems.
• Strong technical writing and documentation skills.
• Bilingual (English and Spanish) required.

Preferred Qualifications

• Experience with TFF systems and weighing/load cell systems.
• Familiarity with regulated automation and instrumentation environments.
• Ability to manage multiple validation deliverables under project timelines.
• Strong communication and cross-functional collaboration skills.

All your information will be kept confidential according to EEO guidelines.