Validation Engineer III

Company: AGC Biologics
Location: Boulder
Posted on: August 1, 2022

Job Description:

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

Summary

AGC Biologics is seeking an energetic and enthusiastic individual with a strong background in Validation or Engineering to join the Validation Team within the Quality Group. This position will primarily contribute to the qualification and validation of production equipment, SIP, autoclave, glass washers, instruments and utilities.

PRINCIPAL Responsibilities

• Writes and executes protocols, performing sampling, reviewing and writing final summary reports based on data.
• Performs qualifications/ re-qualifications of facilities, utilities, manufacturing and analytical equipment to demonstrate that the equipment is fit for its intended use
• Performs validation activities defined by validation master plans, procedures and protocols
• Performs temperature mapping studies for SIP Circuits and Autoclave chambers to validate cycles
• Apply validation/engineering concepts and company procedures to generate validation protocols and reports
• Develop validation program SOPs
• Provide oversight of protocol execution by contract resources
• Determine test scripts and acceptance criteria based on system URS requirements and standards
• Investigate, resolve and close deviations and associated CAPAs
• Provides technical review of validation deliverables
  Knowledge, Skills & Abilities
  
  • Must be able to generate qualification protocols (IQ, OQ, PQ) and summary reports
  • Ability to perform temperature mapping activities and using the Kaye Validator and ValProbes systems preferred
  • Knowledge of system validation "life-cycle" concept
  • Capable of independent planning/organization/execution of personal workload
  • Must have excellent written communication skills to develop and write technical documents, procedures and protocols
  • Must be capable of effectively presenting information to managers and co-workers
  • Must be able to document and perform validation deviation investigations
    Education/Experience
    
    • Bachelor's degree in Life Sciences, Engineering, or related discipline with 5+ years of experience
    • Previous experience in a regulated pharmaceutical, biotechnology or medical device environment a distinct plus
      Compensation Range
      
      $87,417- $104,900 annually
      
      AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
      

Keywords: AGC Biologics, Boulder , Validation Engineer III, Engineering , Boulder, Colorado