POSITION OBJECTIVE: In this hands-on role, you will be responsible for leading and executing the implementation of facility, utility, manufacturing and laboratory systems and the validation of processes at Athenex Pharma Solutions (APS). You will also ensure ongoing compliance through the maintenance of the established programs for validation and calibration.
Essential Job Functions/Responsibilities
- Ensures Quality by Design principles are engaged throughout system lifecycle.
- Responsible for the qualified state of equipment and validated processes used at APS to maintain the site-specific Validation Master Plan and compliance to the relevant regulatory requirements. This includes manufacturing equipment, laboratory instrumentation, computerized systems, utilities, and facilities; process validations, cleaning validations, and media fill validations.
- Maintains periodic re-qualification/performance verification schedule for process validations as required and ensures timely completion of required tasks.
- Ensures required calibration of instrumentation is performed in a timely manner; maintains open communication with calibration contractors to ensure accuracy of data, and timeliness of completion and associated reports. Coordinates investigation of out of limit devices with impacted departments.
- Ensures that all critical modifications and changes to qualified or validated items are assessed for their impact to manufacturing, testing, and/or product.
- Maintain and organize documentation needed for regulatory and financial compliance by maintaining the appropriate project and/or equipment files.
- Leads and develops members of his/her team to optimize facility processes and capabilities through site planning and evaluation of production requirements.
- Communicate with external and internal customers effectively and positively.
- Coordinate information flow from external sources (ex., vendors) to internal departments and leadership to ensure that facility impact and resources have been evaluated.
- Collaborate with various departments (e.g. Operations, QC) and individuals (e.g. peer Project Leaders) to gather information that may impact production and product deliveries schedules.
- Responsible for ensuring that safe work environments and procedures are available and built into the systems and processes.
- Contribute to continuous improvement initiatives; provide review and feedback to maintain compliance and provide cost effective solutions.
- Represents APS during regulatory audits.
- Support and manage facility project work to ensure that each project meets expectations in terms of time and cost.
- Monitors the status of projects, orders, and materials requirements leading up to installation and implementation of equipment, using appropriate tracking tools. Recognizes where expedition of specific aspects is necessary and provides the necessary feedback to all stakeholders.
Required Education & Qualifications
- Engineering-related Bachelor’s degree or equivalent scientific degree in Chemistry or Microbiology.
- 5 years of experience in Engineering or Validation of equipment and\or systems in a pharmaceutical GMP environment.
- Experienced in leading and developing a team of engineers and technicians; may also provide development/leadership to peers and other professionals (e.g., pharmacists)
- Excellent written and verbal communication skills.
- Professional and amiable disposition and communication style needed.
- Excellent follow through skills required.
- Must have a valid state driver's license
- Must also be able to lift up to 25 pounds on a regular basis
- National travel requirements up to 15% of time
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.