|Job Title||Validation Director|
|Location||College Station, TX 77845|
|Description||Summary: The Validation Director is responsible for designing, maintaining and continually improving the validation system in line with current standards and will provide leadership and manage the day to day operations of the validation team.
· Direct the day to day activities of the validation group.
· Direct the day to day activities of validation contractors
· Provide expert guidance and to the validation team in establishing policies, procedures and strategies that are consistent with CGMP, International guidance and Quality Programs
· Design and implement facilities and equipment qualification and validation protocols.
· Develop and implement a revalidation schedule for qualified systems.
· Design and implement Process Validation Plans that include Facility, Process and Cleaning.
· Work with manufacturing to design and implement cycle development studies in areas such as sterilization and product contact cleaning assessment validation studies.
· Participate in annual site audits.
· Work closely with clients in a CMO environment aligning their quality requirements with the internal core Quality Program.
· Complete all validation documentation in a timely and compliant manner including participation in the review of validation documentation to obtain QA sign-off.
· Raise, investigate and close-out exception reports and non-conformances, associated with validation studies.
· Focus on continuous improvement – ability to evaluate systems to improve system functionality and efficiency.
Required Skills & Abilities:
· Hands on experience in Commissioning, Qualification and Validation activities (CQV) to include:
o New facility CQV activities and scheduling
· Good working knowledge of cGMP and regulatory standards for validation.
· Experience in writing and reviewing SOPs and protocols for accuracy, traceability and compliance.
· Experience in performing and leading validation studies within the pharmaceutical and biotechnology industry.
· Proficiency with Microsoft Office products, including Word, Excel, Outlook, PowerPoint and other analytical applications
· Excellent written and oral communication skills.
· Strong analytical and problem solving skills and experience applying these skills to resolve technical problems.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
· Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
· Have a normal range of hearing and vision.
· Undergraduate degree (Engineering, Chemical Engineering or Mechanical Engineering, Biochemistry, Molecular Biology, Microbiology, Chemistry, etc.). Advanced degree preferred.
· At least 10 years of experience in Validation in a GMP environment. Vaccine production compliance experience a plus.
· Experience in new facility construction, commissioning, qualification and validation a plus
· At least 6 years of supervisory/management experience.