Validation Lead - Los Angeles, United States - LS Solutions Inc

Description

Role: Validation Lead

Location: Los Angeles, CA, 90039

Duration: Long Term Contract

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Job Description:

• Develop validation documentation such as validation plans, functional design specifications, test protocols, and standard operation procedures for computerized systems used in the GMP environment Analyze complex manufacturing business processes and identify, evaluate, develop, and/or redesign systems, processes, and procedures to meet user requirements on large initiatives.
• Create detailed written user requirements.
• Responsible for planning, scheduling, and leading validation assignments.
• Must demonstrate competent and effective planning, coordination, and organizational skills.
• Participate and work closely with cross-functional team members (Engineering, Manufacturing, , Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to develop the validation strategy and system validation requirements based on concepts of risk-based CQV which includes user requirements, functional specifications, design specifications, commissioning, and validation.
• Emphasis is on following regulatory guidelines and industry standards.

Education and Skills Requirements:

• Must have experience with pharmaceutical/biotech validation which includes the writing and executing of protocols and standard operating procedures.
• A bachelor's degree in an engineering discipline is required.
• 7+ years of related experience Working knowledge of testing concepts, verification, and validation techniques, defect management, and risk management
• Experience in manufacturing processes and control systems,
• Strong knowledge of GMPs, FDA, and EU guidelines/requirements, is required.
• Must be considered a proficient Subject Matter Expert (SME) in all validation elements.