Job Openings

Supervisor, Equipment Requalifications

Supervisor, Equipment Requalifications
Melrose Park, Illinois

SUMMARY

Responsible for managing the Requalification Department including equipment related systems requalification, critical area airflow pattern testing and HEPA filter integrity/velocity testing. He/She is also responsible for budget management, training, development and performance of department personnel. Off-shift hours are periodically required.

RESPONSIBILITIES

• Manages the day-to-day activities of the department personnel to include assignment of tasks, scheduling, and coordination across the various plant functional areas.
• Responsibilities within the plant include:  Re-qualification of existing equipment, HEPA filters, qualification/Re-qualification of new component qualifications.
• Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA), maintaining compliance within the department.
• Communicates and reports the status of each project to the management and department that sponsors the project. Communication includes project status, milestones, and any additions to the scope of the project as well as regular updates in the form of written reports and oral presentations to senior management.
• Directs requalifications projects by coordinating contractors or site personnel, reviewing the generated reports and implementing any changes or recommendations that result from the studies.
• Revises existing SOPs and is capable of developing new SOPs for systems/equipment.
• Mentors and develops new hires regarding teamwork, requalification techniques and procedures to ensure cGMP compliance.
• Interfaces with the FDA or other regulatory body relative to equipment and control system issues or critical processes.

REQUIREMENTS

• Minimum 4-year degree in a Science or Engineering field of study; or equivalent experience.
• Installation, Operational and Performance Qualification protocol generation and execution.
• PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency.
• Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques.
• Understanding of statistical analysis tools and methods.
• 2-4 years of related experience in a cGMP facility.
• Knowledge of cGMP room classifications, HEPA filter testing and Airflow Pattern testing tools and techniques.
• Knowledge of cGMP Cleaning Validation requirements and techniques.
• Knowledge of cGMP Process and Product Validation requirements and techniques.
• Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques.
• Knowledge of Depyrogenation/Sterilization requirements and techniques.

EOE/M/F/VF/D