Validation/Commissioning Specialist
Jornada completa
QRC Group, Inc
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 Description
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.
Qualifications
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.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Vacante publicada el 3 días atrás
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