POSITION OBJECTIVE: Responsible for providing lifecycle support of validation functions related to sterile and non-sterile pharmaceutical product manufacturing processes and their equipment, utilities, facilites, 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.


This position is based on site in our Dunkirk, New York facility. Remote work is not an option for this role.


Essential Job Functions/Responsibilities

  • Leads and executes validation projects: Prepares and executes protocols including Installation, Operational, and Performance Qualification protocols for equipment, facility and critical classified area protocols, computerized systems; cleaning validation protocols, aseptic process validation protocols; prepares User Requirements Specifications; reviews vendor provided protocols against Athenex validation standards. Participates in vendor led Factory Acceptance Tests and Site Acceptance Tests.
  • 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. 
  • Coordinates and communicates all required testing with affected functional groups and evaluates test results. Accurately records and evaluates test results and observations.
  • Conducts Validation deviations where necessary and determines impact to the qualification and process. 
  • Analyzes and compiles data, composes a final report and circulates for approval. 
  • 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.
  • Equipment the Validation Engineer I may qualify includes, but is not limited to:
  • Manufacturing Systems: formulation equipment, filling lines (syringe, vial, etc.), lyophilizers, terminal sterilizers, autoclaves, manual aseptic operations, liquid inspection systems, packaging and labelling equipment, and serialization systems.
  • Critical Utility Systems: Purified Water, Oil Free Compressed Air, Water for Injection, and Clean Steam.
  • Facilities and Critical Cleanrooms, Environmental Monitoring System, utilities SCADA systems.
  • Analytical Laboratory Instrumentation and Supporting Systems.
  • Computerized systems that are components of the listed systems.
  • 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 WNY sites as needed and for training. 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.




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.

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