Senior Validation Specialist

Description:

We are seeking an experienced Senior Validation Specialist to join Mariana’s MS&T organization, advancing personalized medicine and radiopharmaceuticals. The Senior Validation Specialist will oversee and execute validation and metrology activities for equipment, facilities, utilities, and processes to ensure compliance with regulatory standards and company policies. This role involves planning, developing, and managing validation protocols, metrology programs, and reports to maintain a state of control within operations. The ideal candidate will possess deep technical expertise, strong problem-solving skills, and a commitment to continuous improvement in the specialized field of radiopharmaceutical production.

Illustrative Breadth of Responsibilities:

·       Develop and execute validation protocols (IQ, OQ, PQ) for new and existing equipment, systems, and processes in radiopharmaceutical production.

·       Perform risk assessments and validation gap analyses to prioritize activities.

·       Implement and manage metrology programs, including calibration and maintenance of critical instruments and equipment.

·       Ensure all validation and metrology activities comply with cGMP, FDA, EMA, and other applicable regulatory requirements specific to radiopharmaceuticals.

·       Prepare detailed validation reports, deviations, corrective action plans, and metrology documentation.

·       Create, maintain and manage the Validation Master Plan (VMP) and Metrology Master Plan (MMP).

·       Work closely with quality assurance, manufacturing, quality control and CMC teams to ensure seamless implementation of validation and metrology activities.

·       Provide subject matter expertise during internal and external audits, including those focused on radiopharmaceutical production.

·       Identify and implement process and metrology improvements to enhance efficiency and compliance.

·       Stay updated on industry trends, regulatory changes, and best practices in validation and metrology within the radiopharmaceutical sector.

·       Develop calibration schedules and procedures for radiopharmaceutical manufacturing instruments, ensuring precise and accurate measurements critical to product quality.

·       Evaluate and troubleshoot metrology issues to prevent deviations and ensure uninterrupted production operations.

Requirements/Skills:

·       Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.

·       Minimum of 5 years of experience in validation and metrology within the radiopharmaceutical, pharmaceutical, biotechnology, or medical device industry.

·       Proven expertise in equipment qualification, process validation, cleaning validation, and metrology program management.

·       Familiarity with validation lifecycle principles, metrology standards, and regulatory guidelines (e.g., FDA, ICH Q8-Q11, ISO standards).

·       Proficient in statistical analysis, validation software tools, and metrology calibration equipment.

·       Excellent written and verbal communication skills.

·       Strong organizational and project management abilities.

·       Ability to work collaboratively in a fast-paced, regulated environment.

Mariana Oncology’s Principles

·      Building a Legacy

·      Execution Excellence

·      Courage of our Convictions