Director of Validation

2 days ago

Fort Lauderdale, Florida, United States Transpire Bio Full time
Job Summary

The Director of Validation will independently prepare, review, and execute high-quality qualification, validation, and reports within company timelines and following regulatory guidelines and applicable laws. This role will oversee all qualification/validation-related work with respect to facility and processes as it pertains to a cGMP facility. The incumbent will manage, mentor, and train junior staff to support ongoing operations.

Key Responsibilities
  • Function as the Subject Matter Expert (SME) for the validation policy within the company, focusing on Equipment, Facilities, and Cleaning Validation.
  • Oversee, develop, and execute validation protocols associated with the installation, operation, and performance qualification and requalification of equipment, utilities, and processes used in the manufacture of aseptically/non-aseptically produced inhalation products.
  • Provide technical expertise during design, evaluation, and procurement of new equipment, utilities, or processes.
  • Develop and maintain a Validation Master Plan (VMP).
  • Generate and maintain life cycle documentation for equipment and systems, including User Requirements Specifications, Functional Specifications, Hardware Design Specifications, Software Design Specifications, and Configuration Specifications.
  • Support all aspects of the Validation Life Cycle, from design through operation and improvement.
  • Plan, coordinate, and manage site-specific validation project activities, including protocol development/approval, work schedules, and lifecycle documentation.
  • Review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis.
  • Provide and document training to personnel performing validation activities.
  • Provide technical input to address validation deviations and provide assessments for change requests and identify qualification requirements to ensure compliance to GMPs and that the validated state is maintained.
  • Coordinate protocol approvals and produce accurate summary reports.
  • Develop or contribute to the development of SOPs related to equipment or processes for which the incumbent serves as SME.
  • Remain current with FDA guidelines and requirements regarding the validation of aseptic/non-aseptic manufacturing processes; ensure all work is performed and documented following existing company policies and procedures, as well as cGMP and health and safety requirements.
  • Interface with Quality and Manufacturing groups to facilitate and drive validation execution and completion.
Requirements
  • Bachelor's Degree (BA/BS) in Life Sciences, Engineering, Technical, or equivalent work experience.
  • 10+ years of pharmaceutical industry experience with 5+ years of GMP experience; new facility start-up experience preferred.
Skills and Abilities
  • Time management, organization, and planning skills, multi-tasking, and prioritization skills in a fast-paced environment.
  • Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.
  • Excellent written and verbal communication skills and interpersonal skills.
  • Ability to communicate effectively and collaboratively as part of a team in a respectful manner.
  • Ability to work independently, self-starter.
  • Good problem-solving skills and analytical ability.
  • Strong knowledge and understanding of cGMP regulations and practices pertaining to validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations, and industry trends.

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