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Director of Validation
  • Validation
  • Fort Collins
  • $0- $0
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Hamlyn Williams have partnered with one of the world's leading Global Biotechnology company that have a strong focus on  urology, oncology and dermatology. Due to rapid growth and an innovative pipeline from this Global Biotechnology company, my clients are looking to meet demands of the company by looking to take on a Director of Validation that will lead the validation team on a permanent basis.

As the Director of Validation, you will be leading and executing process, cleaning, facilities, aseptic, fill/packaging, and automation validation for all nearby production locations while working in a collaborative environment. The position ensures that validation activities related to product launches, technology transfers, and remediation are completed on schedule, in accordance with company policies and procedures, and in accordance with the recommendations and specifications of international regulations such as the CFR and ISO. They’re aware that the market value is going up, therefore are offering flexibility and a very generous, lucrative, overall compensation package. 

As a Director of Validation, you will be involved in:

  • Provide leadership in a fast-paced production environment with high quality and regulatory standards; supervise the Validation Specialists and Validation Engineers
  • Provide direction, mentoring, coaching and development towards personal growth, enhanced job performance and career satisfaction
  • Create, write and update validation guidelines, policies and procedures
  • Develop and update the Validation Master Plan for the manufacturing sites (Fort Collins and Windsor, CO) on an as-needed basis
  • Work with the production, engineering, maintenance, and development departments to assure that all required prerequisite documentation is appropriately developed to support process, cleaning, facilities, aseptic, filling/packaging and computer validation activities
  • Track and provide technical direction to validations of aseptic and semi-solid manufacturing to ensure compliance with internal policies and procedures, current industry standards, cGMPs and current regulatory requirements
  • Review product transfer protocols and reports and design/develop a validation strategy
  • Provide validation support to Dermatology and Aseptic manufacturing, assess impact to product quality and determine appropriate actions
  • Create, write and execute required validation protocols and reports
  • Coordinate validations for equipment and/or processes with outside vendors
  • Participate in audits and follow up on corrective actions
  • Conduct and participate in investigative meetings relating to validation manufacturing test failures. Assess impact of production deviations
  • Review and approve all validation test protocols and final reports
  • Maintain up-to-date knowledge of cGMP regulatory issues, particularly pertaining to validation, and ensure that company validation policies and procedures are updated accordingly
  • Contribute to the development of departmental budget and monitor expenditures

As a Director of Validation, you will require:

  • Bachelor’s Degree in scientific or engineering discipline required
  • Ten or more years of experience in the pharmaceutical or medical device industry in quality assurance or validation
  • Five or more years of experience performing validation activities in an aseptic environment
  • Five years in a leadership role required

Please get in touch with me for more details by applying and sending across your resume if this role is of interest. 

PLEASE NOTE: The client can offer visa sponsorship and relocation package

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