Director, Validation

Job Summary

The Director - Validation independently prepares, reviews, and executes high quality, Qualification, Validation and Reports within company timelines and following regulatory guidelines and applicable laws. The incumbent will oversee all qualification / validation related work with respect to facility and processes as it pertains to a cGMP facility. They will manage, mentor and train junior staff to support on-going operations.

Essential Functions

The incumbent will function as the Subject Matter Expert (SME) for the validation policy within the company. Focusing on Equipment, Facilities and Cleaning Validation, the incumbent will oversee, as well as 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.

• The SME will provide technical expertise during design, evaluation and procurement of new equipment, utilities, or processes.
• Incumbent will 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 the technical input to address validation deviations and provide assessments for change requests and identify qualification requirements to ensure compliance to GMP’s 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 guidance’s and requirements regarding the validation of aseptic / non-aseptic manufacturing processes; ensures 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.
• Additional Responsibilities
• Ability to read / interpret engineering drawings and design documents.
• Ability to manage multiple projects at a time.
• Strong knowledge of MS-Office software and PC Skills required.
• Good technical writing skills.
• Excellent communication, problem-solving, planning and organization skills.
• Ability to work independently, including making sound decisions and managing priorities that are in alignment with site and company directives.
• Ability to mentor and direct junior team members.
• Ability to work within a team-oriented environment.
• Ability to work off hours and weekends.

Education

Skills And Abilities