CSV Specialist (Remote Position)

Mentor Technical Group (MTG) provides specialized technical support and solutions for FDA-regulated industries. MTG is recognized for its expertise in life sciences engineering, ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy standards. Resources considered for this RFP will support pharmaceutical manufacturing operations and must meet the following minimum qualifications.Responsibilities:Support Commissioning and Qualification (C&Q) activities for plants and equipmentDevelop, review, and maintain commissioning and qualification procedures and documentationWrite, review, and approve C&Q protocols and reports for various systems, including HVAC, utilities, production equipment, and lab equipmentExecute commissioning and qualification activities and coordinate with internal teams and external consultants to ensure timely deliveryManage change controls and deviations related to plants and equipmentSupport maintenance and calibration functions to improve compliance and qualityProvide expertise in troubleshooting and root cause investigationsFacilitate the transfer of technical knowledge across units and sitesQualifications / Requirements / Knowledge / Skills:Proven background in pharmaceutical product manufacturing, specifically in sterile packaging operationsDemonstrated experience in Commissioning and Qualification (C&Q) activitiesStrong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirementsMore than 5 years of experience in Equipment and Computer System Validation within pharmaceutical facilitiesExperience with digital validation solutions (e.g., ALM or equivalent)Excellent skills in writing validation, commissioning, and technical documentation in EnglishProficient in MS Office applications (Word, Excel, PowerPoint, etc.)Bilingual: fluent in English and SpanishMentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.Powered by JazzHRWu2wji38b9