POSITION OBJECTIVE:          Lead and execute qualification of new facilities, utilities, equipment and computerized systems, validation of new processes and calibration of all critical measurement devices and instrumentation at our Dunkirk manufacturing facility. Ensure the continued validated state of the facility using a Quality by Design lifecycle approach. Interact with Engineering, Facilities/Maintenance, Quality groups, and other facility departments to perform these tasks. Scope includes design, specification, evaluation, installation, calibration and qualification of equipment and new technologies for consistent and repeatable aseptic and sterile production systems, facilities, and related analytical systems.  

Essential Job Functions/Responsibilities

·      Responsible for establishing and maintaining the validated state of equipment and processes used at the Dunkirk Manufacturing Facility, including related documentation lifecycles.

·      Establishes and maintains the asset master inventory for the site. Ensures the timely calibration of all identified devices throughout the facility and laboratories to maintain accurate and dependable readings and test results. 

·      Leads the execution of the site master validation plan with specific focus on development and validation of manufacturing processes, both manual and automated, sterile and non-sterile.

·      Leads the program supporting the validated lifecycle of equipment and processes used at the facility from project initiation to decommissioning. This includes manufacturing (formulation, filling, and packaging) equipment; analytical instrumentation; computerized systems (process control and data acquisition systems); cleaning, process, and media fill validations; periodic re-qualification and calibration of critical equipment and environments.

·      Coordinate information flow from vendors to internal departments and leadership to ensure that facility impact and resources have been evaluated for validation and calibration activities. These needs must be communicated effectively and accurately.

·      Collaborate with various departments (e.g. Operations, QC) and individuals (e.g. peer Project Leaders) to gather information that may impact production, systems, or processes.

·      Leads Acceptance Tests, Installation/Operation/Performance Qualifications for equipment and instruments. Leads Process Validations for products and initial media fill validations for sterile products. 

·      Leads members of his/her team to optimize facility process flow and capabilities through site planning and evaluation of production / capacity requirements and limitations.

·      Contributes to achieving continuous improvement, review processes to maintain compliance and provide cost effective solutions.

·      Support and manage facility project work to ensure that each project meets expectations in terms of time and cost.

·      Monitor the status of the project stages leading up to execution and during execution, expediting where necessary, and provides information to appropriate individuals/departments regarding status.

·      Create and maintain project delivery schedules based on available information.

·      Maintain and organize documentation needed for Regulatory and financial compliance through compilation of paper and electronic files containing the appropriate project information.

·      Participates in site regulatory inspections.

·      Follow requirements of GMP for equipment, processes, and systems.

·   Ensure that all critical changes are impact assessed and that appropriate controls/actions are in place to secure ongoing manufacture.

·      Training of staff in validation and calibration procedures and principles.

·      Other responsibilities as may be assigned.

Required Education & Qualifications

·      Bachelor’s degree in Engineering or related science field

·      Minimum of 7 years of experience in validation and calibration of systems in a GMP environment with at least 3 years of those years in a team leadership role

·      Experience in validation lifecycle approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc.).

·      Experience in calibration methodology, equipment and instrumentation.

·      Working knowledge of Quality by Design (QbD) principles and approach; aseptic processing validation elements such as: media fill validations, good aseptic techniques, qualification of classified clean rooms; qualification of sterilizer processes; cleaning validation for pharmaceutical processing equipment.

·      Knowledge and experience in cGMP CAPA, root-cause analysis, risk assessment and investigation tools and techniques.

·      Excellent written, oral, instructional, presentation, and interpersonal skills  

·      Strong leadership and mentorship capabilities with the ability to encourage and motivate

·      Excellent analytical and problem-solving skills

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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