Director of Validation Biotherapeutics
FPCNational - New Mexico

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My client is a rapidly growing start up contract organization specializing in advanced Biotherapeutic & Drug Development with a specific focus on early stage process development through Phase III clinical runs with 80% of the current product being sterile injectables.

I am assisting them in locating a Director of Validation who will report directly to the Senior Vice President, of Quality and be responsible for designing, maintaining and continually improving the validation system in line with current industry standards.

The ideal candidate will be a hands on leader with experience establishing validation policies, procedures and strategies within a vaccine cGMP facility. Someone with experience in new facility construction, commissioning, qualification and validation would be a plus.

Essential Functions:
• 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.
• Work closely with clients in a CMO environment aligning their quality requirements with companies internal core Quality Program.
• 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
o Process
o Cleaning
• 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.

• Undergraduate degree (Engineering, Chemical Engineering or Mechanical Engineering, Biochemistry, Molecular Biology, Microbiology, Chemistry, etc.). Advanced degree preferred.
• At least 7 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 5 years of supervisory/management experience.

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FPCNational - 2 years ago - save job