POSITION OBJECTIVE: To ensure APS manufacturing, laboratory equipment, process and system validations are compliant and cost effective. Independently develops, supports and validates aseptic and sterile manufacturing processes in a GMP environment. Interact with internal departments QC/QA, manufacturing. Scope may include design, specifications, evaluation, calibration of equipment and new technologies for reliable, cost effective aseptic and sterile production systems . Oversee the stability chambers in addition to temperature controlled storage. Oversee the calibration and preventative maintenance of all equipment and facility monitoring systems in area of responsibility. May guide and train operations personnel on the use of manufacturing equipment and processes.
ESSENTIAL JOB FUNCTIONS/RESPONSIBILITIES:
· Supports the IQ/OQ/PQ of new equipment this includes manufacturing equipment, process and system validations, routine qualifications, calibrations and preventative maintenance.
· `Troubleshoot equipment as needed to identify and initiate corrective actions.
· Monitor and collect data regarding systems / equipment performance / process performance. Identify existing problems and recommend solutions.
· Project management of vendors, projects and programs to ensure adherence to schedules and timelines
· Establish a tracking system for all calibrations activities across Athenex to manage and prevent compliance issues
· Coordinate information flow from vendors to internal departments and leadership to ensure facility impact and resources have been evaluated and communicated.
· Collaborate with all various departments (e.g. Operations, QC, QA), including leadership to gather information that may impact production and product deliveries to customers.
· Responsible for enforcing and working in compliance with safe work practices and procedures; properly uses personal protection and follows safety requirements at Athenex, reports any injury or illness immediately and notifies APS of any hazards, unsafe acts or conditions in the workplace. Responsible for compiling vendor’s certificates and insurance for all projects and jobs.
· Leads continuous improvement projects, reviews processes to maintain compliance and provide cost effective solutions.
· Lead engineer that oversees complex projects, orders appropriate equipment in a timely manner and determines materials requirements leading up to installation and implementation of equipment.
· Leads development and manufacturing processes which includes; manufacturing flow diagrams, SOP’s, for production, training personnel and create appropriate production documentation.
· Create and maintain project delivery schedules.
· Maintain and organize documentation needed for regulatory and financial compliance through compilation of both physical files and computer files containing appropriate project information.
· Follow requirements per cGMP / CFR regulations.
· Responsible for providing technical support in manufacturing operations, equipment, facilities across all departments
Responsible for process design, process validation and qualification for new products and existing products and processes.
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.