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Company Description QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.Log on now to our website. qrcgroup.Com / to learn more about our services and solutions!Job DescriptionWe 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 OverviewThe selected candidate will support commissioning, qualification, validation, and documentation activities associated with the installation and startup of the new system.Position ResponsibilitiesExecute 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.QualificationsMinimum RequirementsBachelor'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 QualificationsExperience 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.Additional InformationAll your information will be kept confidential according to EEO guidelines.

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📌 Validation/Commissioning Specialist (Manatí)
🏢 Qrc Group
📍 Manatí