QRC Group, Inc
Pharmaceutical
Validation/CommissioningSpecialist
Neural analysis suggests this role is
optimal for executive candidates.
“Validation/Commissioning Specialist at QRC Group, Inc. Skills: Validation, Commissioning, cGMP regulations, Technical writing. Execute commissioning and qualification activities. Support installation, operational, and performance qualification protocols”
Industry & Context.
What They're Looking For.
Must Have
Bachelor’s degree in Engineering, Sciences, or related technical field, Background in pharmaceutical manufacturing environments, Experience in commissioning and qualification activities, 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, technical writing and documentation skills, Bilingual (English and Spanish) required
Nice to Have
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, communication and cross-functional collaboration skills
What You'll Do.
Execute commissioning and qualification activities
and performance qualification protocols
Ensure compliance with cGMP regulations
Develop and review validation documentation
Coordinate validation activities
Support computer system validation activities
Utilize digital validation management systems
Collaborate with teams
How You'll Work.
Team & Collaboration
Collaborate with engineering, manufacturing, quality, and validation teams; communication and cross-functional collaboration skills
Communication Scope
Bilingual (English and Spanish); communication and cross-functional collaboration skills
Process & Methodology
Manage multiple validation deliverables under project timelines
Full Job 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 http://www.qrcgroup.com / to learn more about our services and solutions! 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 wit
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