Quality Assurance Validation Scientist

Ensure validation activities for equipment, facility, utilities, cleaning and sterilization validation meet site requirements and compliance with pharmaceutical industry regulations (e.g., FDA, EMA, PIC/S). Provide Quality Validation oversight and technical expertise to the Tech-Ops Validation Department and other functions. Ensure compliance to cGMPs and support regulatory inspections.

Key Responsibilities/Essential Functions

• Actively demonstrates the Lantheus values of accountability, collaboration, customer service, quality, efficiency and safety
• Support for Quality review/approval of commissioning documentation, validation protocols, reports and support records to ensure compliance with local procedures; ensure timely resolution of documentation, compliance, and quality system issues
• Provide Quality oversight of validation protocols, documents and procedures for manufacturing equipment, utilities, automation, cleaning and sterilization validation. Work with Technical Operation Validation team to resolve any protocol discrepancies. Provide technical expertise, as required
• Assist in maintenance of the Site Validation Master Plan to ensure compliance with pharmaceutical industry requirements and global regulations (e.g., FDA, EMA, PIC/S)
• Actively promote safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards
• Participates in project team meetings to represent Quality Validation to meet established timeframe for project implementation that support business needs
• Support internal and external inspections as a subject matter expert for validation and provide audit support, as required
• Collaborate well with functional departments and project teams. Communicate effectively with Technical Operations Validation management and other functional departments
• Support continuous quality system improvements for the validation program
• Support the development of validation execution strategies and timelines with validation management and project team for manufacturing equipment, utilities, automation, cleaning and sterilization validation

Basic Qualifications

• Ability to recommend and make good decisions in complex situations
• Bachelor’s degree in science or engineering with 5+ years of experience in pharmaceutical or biopharmaceutical industry with at least 2 years in validation
• Knowledge of cGMP requirements and relevant government regulations (FDA, EU, JP, etc.)
• Strong organizational, presentation and communication skills
• Knowledge of computer systems used for report writing or data presentation (Microsoft Word, Excel, PowerPoint)
• Knowledge of Validation global compliance regulations with emphasis in Terminal Sterilization and Aseptic Processing
• Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred
• Validation experience with HVAC, utilities, and vial filling line equipment and cleaning and sterilization cycle development and validation experience is desired
• Ability to work in a team oriented environment and represent the Quality organization on multi-disciplinary teams

Other Requirements

Less than 10% expected travel