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Validation Specialist I/II

2 months ago

Boulder, Colorado, United States KBI BioPharma Full time

Job Overview

As a key member of the Validation Department, the Validation Specialist I/II plays a crucial role in overseeing the validation lifecycle process to ensure compliance with cGMP manufacturing standards for biopharmaceutical products. This position is designed to support multiple areas of expertise within validation disciplines, which may encompass:

  • Qualification of Facilities
  • Qualification of Utilities
  • Qualification of Equipment
  • Qualification of Manufacturing Process Control Systems
  • Cleaning Validation
  • Steam Validation
  • Air Visualization Studies
  • Mixing Studies

The individual will actively cultivate expertise in at least one specific discipline.


Key Responsibilities

The Validation Specialist will assist in making informed technical decisions regarding validation strategies and requirements for various projects and change controls. This role is essential for the successful implementation of validation strategies within a multi-product manufacturing environment. Responsibilities include:

  • Drafting, executing, and reviewing validation documentation, deviations, CAPAs, and change controls.
  • Ensuring adherence to all Quality System and cGMP documentation and data integrity requirements.
  • Conducting risk and impact assessments related to engineering and prerequisite validation processes.
  • Reviewing Engineering Specifications (URS, FRS, DDS, etc.).
  • Providing operational support in executing validation requirements, responding to audits, and preparing for inspections.
  • Leading and supporting initiatives aimed at enhancing business and operational excellence.

Work may occasionally require validation protocol execution and engineering studies to occur outside of standard hours to align with equipment availability and manufacturing schedules.


Qualifications

To be considered for this position, candidates should possess:

  • A minimum of a Bachelor's degree in a scientific, biochemical, or engineering discipline.
  • Five or more years of experience in biotechnology manufacturing, particularly in fermentation or cell culture environments, or a Master's degree.
  • A proven track record in quality orientation and customer service, demonstrating respect for individuals and a high level of integrity.
  • The ability to interpret technical documents, including schematic drawings and engineering specifications.
  • Strong written and verbal communication skills.
  • Critical thinking and problem-solving abilities.

Compensation

The salary for Validation Engineer I ranges from $62,000 to $75,000, while Validation Engineer II ranges from $75,000 to $90,000. This range is based on current averages and expectations, and the final salary will be determined by the candidate's qualifications and experience. KBI offers a comprehensive total rewards strategy, including an annual bonus structure, medical, dental, and vision coverage, paid time off, holidays, a sabbatical program, and 401K matching with immediate vesting.


KBI Biopharma is dedicated to maintaining a safe and healthy workplace. Employees must disclose their vaccination status and provide proof of COVID-19 vaccination as per company policy.


KBI Biopharma, Inc. is an equal opportunity employer and actively seeks to diversify its workforce. All qualified applicants are encouraged to apply.