POSITION OBJECTIVE: Responsible for providing lifecycle support of validation functions related to sterile and non-sterile pharmaceutical product manufacturing processes and their equipment, utilities, facilities, analytical instrumentation, and computerized systems. Provides continued technical support to the operations team in equipment, system, utility, facility, and process validation and continued requalification efforts. Participates in improvement teams charged with enhancing the compliance and performance of the plant systems, while considering the regulatory requirements for change control.

Essential Job Functions/Responsibilities

  • Provides and performs risk assessments and evaluates change control requirements when system modifications are required. Executes required re-validation activities when required.
  • Collaborates with facility departments and end users to ensure requirements are documented and delivered in a timely manner.
  • Collaborates with equipment, instrument, and software manufacturers and vendors to design, build and program solutions for Athenex, ensuring delivery of appropriate system and turnover packages in a timely manner.
  • Prepares protocols and develops test plans and scenarios based on site Validation Master Plan and Athenex validation policies/SOPs.
  • Maintains validation lifecycle by performing periodic requalification activities following Standard Operating Procedures (SOPs).
  • Provides and performs risk assessments and evaluates change control requirements when system modifications are required. Executes required re-validation activities when required.
  • Participates in and recommends developments/ improvements to validation programs as needed to comply with current with cGMPs and industry standards.
  • May perform other duties as assigned.

Required Education & Experience

  • Bachelor of Science degree in Engineering or Sciences field is required.
  • 3 years of experience working in a cGMP manufacturing facility is required, Validations experience is preferred.
  • Effective written and verbal communication skills is required; ability to author documentation utilized by a broad range of disciplines. Read and comprehend SOPs, vendor documentation, and other written documentation. Good understanding of statistical mathematics.

Required Skills & Abilities:

  • Ability to write reports with excellent attention to detail and planning.
  • Ability to manage multiple tasks, prepare metrics and meet deadlines.
  • Understanding of cGMPs, industry guidance, ISPE GAMP 5, and aseptic techniques.
  • Understanding of statistical analysis tools, process capability studies and methods.
  • Knowledge and experience in cGMP CAPA, root-cause analysis, risk assessment and other investigation tools and techniques, such as: FMEA, Pareto charts, control charts, gage R&R, etc.
  • Proficiency with current software applications, such as, Office (e.g., Word, Excel, etc.) is required and proficiency in statistical software applications is preferred.
  • Familiar with operation of temperature/humidity dataloggers, aerosol smoke generators, photometers, velocity meters, light meters, volt meters, etc., to perform equipment qualifications and airflow visualization testing and documentation for aseptic processes

Working Conditions:

  • Working conditions include laboratory space; various manufacturing spaces, including aseptic/sterile cleanrooms; warehouses; mechanical spaces where facility equipment and devices are located.
  • Travel between Western New York sites is required: Clarence, West Amherst, Buffalo, and potentially projects in Dunkirk, where pre-planned. Valid NYS driver’s license is required.
  • Must be available to work weekends and off-shift hours as required and pre-planned to support work.
  • Travel to vendor/manufacturer sites is required; domestic and international travel may be required where pre-planned.
  • Able to lift up to 25 lbs.
  • This position requires the passing of a pre-employment drug screen in compliance with federal drug testing rules.

Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. 

Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.

This is a safety sensitive position and/or a position which has the potential to significantly impact the health or safety of other employees or members of the public. It requires passing a pre-employment drug screen in compliance with federal drug testing rules.  

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