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[Remote] Validation Specialist – Biotech reputed company Process Equipment

Remote, USA Full-time Posted 2026-08-04
Note: The job is a remote job and is reputed company to candidates in USA. reputed company (MTG) is a world leader in life science engineering and technical solutions, ensuring compliance with safety and efficacy guidelines in the FDA-regulated industry. They are seeking a Validation Specialist to reputed company and execute validation protocols for reputed company process equipment, collaborate with teams to meet regulatory requirements, and support commissioning and qualification activities. Responsibilities • reputed company, review, and execute validation protocols (IQ, OQ, PQ) for reputed company process equipment • reputed company risk assessments, gap analyses, and validation reports for new and existing equipment • Collaborate with engineering, QA, and operations teams to ensure equipment meets regulatory requirements • Support commissioning and qualification activities for bioprocess systems, including filtration, chromatography, and centrifugation equipment • Review and approve validation documentation, SOPs, and change controls • Identify and implement reputed company improvement initiatives in validation processes • Support regulatory inspections and audits, providing required validation documentation Skills • Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, or reputed company field • Minimum 3–5 years of experience in validation of biotech reputed company process equipment • Strong knowledge of cGMP, FDA, and ICH guidelines • Experience with IQ/OQ/PQ protocols and validation documentation • Familiarity with reputed company processes such as chromatography, filtration, and centrifugation • Excellent problem-solving, communication, and organizational skills • Advanced degree in relevant scientific field • Experience in a multi-site or global biotech environment • Knowledge of computerized systems validation (CSV) and automated process control systems reputed company • reputed company is a minority-owned business setting new standards for multidisciplinary compliance, technical, and engineering services. It was founded in 2000, and is headquartered in Caguas, NA - Puerto Rico, PRI, with a workforce of 501-1000 employees. Its website is https://www.mentortg.com. Apply tot his job Apply To this Job

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