Senior Validation Engineer
POSITION OBJECTIVE: The Senior Validation Engineer is responsible for leading the site Valdiation team who is 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 their computerized systems. The Senior Validation Engineer will lead the efforts of their team to deliver properly designed and validated manufacturing and analytical systems and procedures that meet all Athenex requirements, regulatory requirements, and meet or exceed current pharmaceutical industry standards.
Essential Job Functions/Responsibilities:
- Leads cross functional teams and manages projects in conjunction with vendors, Athenex operational groups, and stakeholders/system users to develop, modify and implement manufacturing and instrumentation systems solutions following Validation Master Plan.
- Manages and oversees all aspects of the project scope, schedule, resources, and testing to drive successful delivery within timelines.
- Leads initial validations and re-validation activities for aseptic/sterile/non-sterile manufacturing, packaging, labelling, serialization, controls and automation, laboratory instrumentation; product process validation, cleaning validation. Systems may include computerized system components such as: controllers, software, hardware, instrumentation and network support. Authors and executes Risk Assessments, Protocols (IQ/OQ/PQ), change controls, and other lifecycle documentation relevant to the project.
- Develops Athenex requirements for system documentation, reviews, and coordinates the project documents prepared by the vendor to document, design, and build the systems.
- Leads project team in execution of qualification protocols (initial, amendment and supplements) in compliance with the company’s validation policies and Good Documentation Practices.
- When anomalies arise, performs or assists on risk assessments on patient safety and data integrity on electronic systems that are deviant from trend or acceptance criteria, applying knowledge of cGMP, FDA 21 CFR Part 11, Root Cause Analysis (RCA) and Quality Management System (QMS) principles to ensure compliance and effective solutions.
- Creates, revises, and updates validation policies and SOPs in support of Validation Master Plans, individual protocols, computerized system changes, and departmental operations.
- Develops validated systems periodic re-qualification strategies aligned with current validation master plan and change control requirements. Coordinates life cycle activities with user departments. Reviews re-qualification activities performed by team members.
- 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.
- Maintains a thorough understanding of regulatory requirements and industry standards for equipment and process validation and is effective in conveying this knowledge to team members and other personnel.
- Supports continuous improvement efforts by monitoring system performance and collaborating with system stakeholders, day-to-day users and vendors to realize process improvements, updated functionality and workflows to address organizational needs and bottlenecks.
- May perform other duties as assigned.
Required Education & Experience:
- Bachelor of Science degree in Chemical Engineering or Biochemical Engineering
- Minimum of 3 years of experience as a Chemical Engineer and/or Quality Assurance role in the pharmaceutical manufacturing industry
- Minimum of 3 years of experience with cGMP 21 CFR 11/210/211 Quality Systems and developing plans for and executive of Change Controls, CAPAs, Deviations, Investigations, Root Cause Analysis and Risk Assessments
- Requires travel 50% of the time to other Athenex offices in Western New York
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.