[Remote] Validation Specialist – Biotech reputed company Process Equipment
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.
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