Senior Quality Assurance Validation Specialist

Overview

• Contribute to a dynamic team as a Senior Quality Assurance Validation Specialist, ensuring compliance and quality standards in biopharmaceutical operations.
• Support validation lifecycle documentation for equipment, automation, facilities, and utilities within a fast-paced, regulated environment.
• Collaborate cross-functionally to uphold quality assurance standards and regulatory compliance for critical projects.
• Utilize expertise in GMP operations to review and approve validation protocols, risk assessments, and technical documentation.
• Leverage technical writing skills to produce clear and precise validation reports and quality documentation.
• Engage in continuous improvement initiatives to enhance validation processes and quality assurance practices.
• Work onsite to ensure alignment with program procedures and quality requirements.

Key Responsibilities & Duties

• Review and approve validation lifecycle documents, including SLRA, DI assessments, and qualification protocols.
• Ensure compliance with FDA and EMA regulations through meticulous documentation and validation practices.
• Represent Quality Assurance Validation in cross-functional meetings to communicate quality requirements.
• Perform risk assessments and oversee validation issues for equipment and utility systems.
• Collaborate on BMRAM work orders for equipment, automation, facilities, and utilities.
• Contribute to continuous improvement efforts to optimize validation processes and documentation.
• Provide technical expertise in cell culture and single-use systems validation.

Job Requirements

• Bachelor’s degree in Engineering, Microbiology, Chemistry, Biochemistry, or related Science field.
• Minimum 8 years of experience in GMP operations, with preferred 10 years in Quality or Validation roles.
• Proficiency in facility, equipment, and utility validation processes; experience with cell culture and single-use systems preferred.
• Strong knowledge of FDA and EMA regulations and their application in biopharmaceutical settings.
• Exceptional technical writing and communication skills for effective documentation and collaboration.
• Ability to work in a fast-paced environment, balancing individual tasks and team collaboration.
• Demonstrated organizational skills and attention to detail in validation and quality assurance activities.
• Commitment to continuous improvement and optimization of validation processes.