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Validation Engineer III CV-SIP

Company: CMC ICOS Biologics Inc.
Location: Boulder
Posted on: May 3, 2021

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 cleaning validation of CIP and SIP cycles, Autoclave cycles, COP baths and parts washer cycle qualifications, IQ/OQ qualification of new equipment, and the maintenance of the validated state.

PRINCIPAL Responsibilities:

  • Writes and executes Cleaning Validation protocols, performing cleaning 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
  • Evaluates the introduction of new products to determine when cleaning verification and validation activities are required
  • Participates in the development of cleaning cycles
  • 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
  • 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
  • Must be able to perform temperature mapping activities and using the Kaye Validator and ValProbes systems
  • Must be capable of taking cleaning validation samples, defining an equipment grouping strategy and identifying the worst-case correlation between products, cleaning procedures and equipment
  • 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 coworkers

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:

$85,070 - $108,040 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: CMC ICOS Biologics Inc., Boulder , Validation Engineer III CV-SIP, Other , Boulder, Colorado

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